Brief Summary
This is a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors
Brief Title
Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors
Detailed Description
This will be a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors. The procedures will be similar in both groups, but there could be more scans in healthy volunteers and fewer in individuals with PDAC or Other Solid Tumors during the same time interval if individuals are intolerant of lying still on an imaging table for long periods of time. All individuals will have vital signs, ECGs, and blood for safety assessments collected before and 2 weeks after a single dose, intravenous (IV) administration of the investigational radiopharmaceutical, RAD301, at a dose of 150 ± 50 MBq (\~ 4 mCi). There will be 3 whole body (WB) PET-CT and PET scanning sessions.
The initial WB acquisition should take approximately 10 minutes. A subsequent WB PET-only scan will be performed approximately 45 minutes after the injection. As time passes and less radioactivity is localizable to the distal extremities, the scan length may be decreased from vertex-to-thighs. The duration of each scan may increase to partially compensate for radioactive decay. More than one WB scan may be performed in healthy volunteers during the first imaging session, but only one scan will be required in individuals with PDAC or Other Solid Tumors who are not able to tolerate additional scans. The entire first imaging session will last up to approximately 2 hours. The individuals will then be given a rest period (lunch break) after which the sequence of imaging scans could be repeated.
This second imaging session (WB PET-CT) will be optional and depends on the robustness of the individual and the availability of the clinical scanner. The second imaging session will take place mid-day, after the break, and will last up to 1.5 hours.
There will be a third, or final imaging session (WB PET-CT) at the end of the day for all participants, which will strive to include the time interval after approximately 4 physical half-lives of Gallium-68 (Ga-68). The third imaging session will last up to 1.5 hours.
The initial WB acquisition should take approximately 10 minutes. A subsequent WB PET-only scan will be performed approximately 45 minutes after the injection. As time passes and less radioactivity is localizable to the distal extremities, the scan length may be decreased from vertex-to-thighs. The duration of each scan may increase to partially compensate for radioactive decay. More than one WB scan may be performed in healthy volunteers during the first imaging session, but only one scan will be required in individuals with PDAC or Other Solid Tumors who are not able to tolerate additional scans. The entire first imaging session will last up to approximately 2 hours. The individuals will then be given a rest period (lunch break) after which the sequence of imaging scans could be repeated.
This second imaging session (WB PET-CT) will be optional and depends on the robustness of the individual and the availability of the clinical scanner. The second imaging session will take place mid-day, after the break, and will last up to 1.5 hours.
There will be a third, or final imaging session (WB PET-CT) at the end of the day for all participants, which will strive to include the time interval after approximately 4 physical half-lives of Gallium-68 (Ga-68). The third imaging session will last up to 1.5 hours.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+1 646 535 5017
Central Contact Email
dv@radiopharmtheranostics.com
Completion Date
Completion Date Type
Estimated
Conditions
Healthy Volunteers
Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer (NSCLC)
Esophageal Squamous Cell Carcinoma
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
1. Must be ≥ 18 years of age at the time of informed consent.
2. All participants must be willing and able to give informed consent.
3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference.
4. Screening laboratory values within 30 days prior to administration of the study drug:
1. WBC ≥ 1200/μL
2. ANC ≥ 1000/μL
3. Platelets ≥ 75,000/μL
4. Hemoglobin ≥ 9.0 g/dL
5. Creatinine ≤ 1.5 mg/dL
6. AST/ALT ≤ 3 x ULN for patients with no liver metastases.
7. AST/ALT ≤ 5 x ULN for patients with liver metastases.
8. Bilirubin ≤ 1.5 mg/dL except for participants with Gilbert's disease.
5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.
6. All participants must have baseline pulse oximetry ≥ 95% on room air.
7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.
8. Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days).
9. Willing to refrain from donating blood for 4 weeks after administration of RAD301.
10. Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor.
Exclusion Criteria:
1. Participant may not be a member of a vulnerable population defined as participants who are not able to understand the nature of the trial and provide informed consent or who have any medical, psychological or sociological condition that in the opinion of the investigator would interfere with the ability to give consent or interfere with protocol compliance.
2. Women may not be pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to administration of RAD301.
3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent.
4. History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of RAD301, including chronic liver or renal failure.
5. Unable to tolerate the study procedures.
6. Patients with brain metastases are eligible as long as there is no requirement for high doses of systemic corticosteroids that could result in immunosuppression (\>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases
7. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results.
8. Clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \>II) or serious cardiac arrhythmia.
9. Other than the tumor types being studied, a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
10. Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
11. Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).
1. Must be ≥ 18 years of age at the time of informed consent.
2. All participants must be willing and able to give informed consent.
3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference.
4. Screening laboratory values within 30 days prior to administration of the study drug:
1. WBC ≥ 1200/μL
2. ANC ≥ 1000/μL
3. Platelets ≥ 75,000/μL
4. Hemoglobin ≥ 9.0 g/dL
5. Creatinine ≤ 1.5 mg/dL
6. AST/ALT ≤ 3 x ULN for patients with no liver metastases.
7. AST/ALT ≤ 5 x ULN for patients with liver metastases.
8. Bilirubin ≤ 1.5 mg/dL except for participants with Gilbert's disease.
5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.
6. All participants must have baseline pulse oximetry ≥ 95% on room air.
7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.
8. Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days).
9. Willing to refrain from donating blood for 4 weeks after administration of RAD301.
10. Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor.
Exclusion Criteria:
1. Participant may not be a member of a vulnerable population defined as participants who are not able to understand the nature of the trial and provide informed consent or who have any medical, psychological or sociological condition that in the opinion of the investigator would interfere with the ability to give consent or interfere with protocol compliance.
2. Women may not be pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to administration of RAD301.
3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent.
4. History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of RAD301, including chronic liver or renal failure.
5. Unable to tolerate the study procedures.
6. Patients with brain metastases are eligible as long as there is no requirement for high doses of systemic corticosteroids that could result in immunosuppression (\>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases
7. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results.
8. Clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \>II) or serious cardiac arrhythmia.
9. Other than the tumor types being studied, a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
10. Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
11. Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).
Inclusion Criteria
Inclusion Criteria:
1. Must be ≥ 18 years of age at the time of informed consent.
2. All participants must be willing and able to give informed consent.
3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference.
4. Screening laboratory values within 30 days prior to administration of the study drug:
1. WBC ≥ 1200/μL
2. ANC ≥ 1000/μL
3. Platelets ≥ 75,000/μL
4. Hemoglobin ≥ 9.0 g/dL
5. Creatinine ≤ 1.5 mg/dL
6. AST/ALT ≤ 3 x ULN for patients with no liver metastases.
7. AST/ALT ≤ 5 x ULN for patients with liver metastases.
8. Bilirubin ≤ 1.5 mg/dL except for participants with Gilbert's disease.
5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.
6. All participants must have baseline pulse oximetry ≥ 95% on room air.
7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.
8. Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days).
9. Willing to refrain from donating blood for 4 weeks after administration of RAD301.
10. Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor.
1. Must be ≥ 18 years of age at the time of informed consent.
2. All participants must be willing and able to give informed consent.
3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference.
4. Screening laboratory values within 30 days prior to administration of the study drug:
1. WBC ≥ 1200/μL
2. ANC ≥ 1000/μL
3. Platelets ≥ 75,000/μL
4. Hemoglobin ≥ 9.0 g/dL
5. Creatinine ≤ 1.5 mg/dL
6. AST/ALT ≤ 3 x ULN for patients with no liver metastases.
7. AST/ALT ≤ 5 x ULN for patients with liver metastases.
8. Bilirubin ≤ 1.5 mg/dL except for participants with Gilbert's disease.
5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.
6. All participants must have baseline pulse oximetry ≥ 95% on room air.
7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.
8. Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days).
9. Willing to refrain from donating blood for 4 weeks after administration of RAD301.
10. Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor.
Gender
All
Gender Based
false
Keywords
Pancreatic Ductal Adenocarcinoma
non-small cell lung cancer (NSCLC)
esophageal squamous cell carcinoma
cervical cancer
endometrial cancer
ovarian cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05799274
Org Class
Industry
Org Full Name
Radiopharm Theranostics, Ltd
Org Study Id
RAD301.2022-001
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors
Primary Outcomes
Outcome Description
Absorbed radiation dose of RAD301 in critical organs
Outcome Measure
Radiation dosimetry of RAD301
Outcome Time Frame
6 hours
Outcome Description
Absorbed radiation dose of RAD301 in tumor lesions
Outcome Measure
Radiation dosimetry of RAD301
Outcome Time Frame
6 hours
Outcome Description
The properties, incidence, nature and severity of AEs and SAEs per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Outcome Measure
Safety and tolerability of RAD301
Outcome Time Frame
4 weeks
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Gunjan Garg
Investigator Email
ggarg@montefiore.org
Investigator Phone
ggarg
Investigator Department
Radiology
Investigator Division
Nuclear Medicine
Investigator Sponsor Organization
External
Study Department
Radiology
Study Division
Please Specify
Categories Mesh Debug
Lung & Chest Cancers --- CARCINOMA, NON-SMALL-CELL LUNG
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Cancer --- CARCINOMA
Lung & Chest Cancers --- NEOPLASMS, GLANDULAR AND EPITHELIAL
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Endocrine System Cancers --- HEAD AND NECK NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Prostate Cancer --- UROGENITAL NEOPLASMS
Gynecologic Cancers --- UTERINE CERVICAL DISEASES
Gynecologic Cancers --- UTERINE DISEASES
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Endocrine System Cancers --- ENDOCRINE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
MeSH Terms
CARCINOMA, NON-SMALL-CELL LUNG
ESOPHAGEAL SQUAMOUS CELL CARCINOMA
UTERINE CERVICAL NEOPLASMS
ENDOMETRIAL NEOPLASMS
OVARIAN NEOPLASMS
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
CARCINOMA, SQUAMOUS CELL
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS, SQUAMOUS CELL
ESOPHAGEAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
HEAD AND NECK NEOPLASMS
DIGESTIVE SYSTEM DISEASES
ESOPHAGEAL DISEASES
GASTROINTESTINAL DISEASES
UTERINE NEOPLASMS
GENITAL NEOPLASMS, FEMALE
UROGENITAL NEOPLASMS
UTERINE CERVICAL DISEASES
UTERINE DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
GENITAL DISEASES
ENDOCRINE GLAND NEOPLASMS
OVARIAN DISEASES
ADNEXAL DISEASES
ENDOCRINE SYSTEM DISEASES
GONADAL DISORDERS