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Clinical Trial Finder

Search Results

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

Study Purpose

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female ≥18 years old with the following histologically confirmed metastatic or recurrent GRPR-expressing tumors: 1.
Metastatic castrate resistant prostate cancer (mCRPC); 2. HR+/HER2- breast cancer; 3. Colorectal cancer; 4. Cervical cancer; 5. Cutaneous melanoma; 6. Non-small-cell lung cancer (NSCLC).
  • - Subjects with recurrent disease must have progressed on at least 2 prior systemic therapies.
  • - For participants with mCRPC: Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
  • - Presence of at least 1 site of measurable disease per RECIST 1.1.
At least 1 identified measurable lesion must show GRPR expression in 203Pb-DOTAM-GRPR1 imaging (uptake greater than that of the liver).
  • - Eastern Cooperative Oncology Group (ECOG) status 0-1.
  • - Sufficient bone marrow, hepatic and renal function, as assessed by the following laboratory requirements: 1.
White blood cell (WBC) ≥2,500/ mm³ 2. Absolute neutrophil count (ANC) ≥1500/mm³ 3. Platelets ≥75,000/mm³ 4. Hemoglobin (HgB) ≥9.0 g/dL; 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) or ≤ 5 x ULN in the presence of liver metastases. 6. Total bilirubin: ≤1.5 x ULN, except if history of Gilbert's disease. 7. Adequate renal function defined by creatinine clearance (CLCR) ≥ 60 mL/min calculated as follows: CLCR = eGFR in ml/min/1.73 m2 calculated by the Modified Diet in Renal Disease (MDRD) x participant body surface area (BSA) in m2 ÷ 1.73. 8. Serum amylase and/or lipase ≤1.5 x ULN.
  • - For women of childbearing potential (WOCBP) and men with partners of childbearing potential: be willing to use highly effective methods of contraception throughout the study and for 7 months (for WOCBP, 4 months for men) after discontinuation of study intervention, as outlined in Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information.

Exclusion Criteria:

1. Impaired cardiac function or clinically significant cardiac disease, including any of the following: 1. Congestive heart failure New York Heart Association (NYHA) class II, III or
  • IV. 2.
Left ventricular ejection fraction (LVEF) <50%. 3. Clinically significant arrhythmias, cardiac arrhythmias requiring antiarrhythmic therapy other than beta blockers or digoxin or digitalis compounds. 4. Fridericia-corrected QT (QTcF) interval >480 ms (Common Terminology Criteria for Adverse Events [CTCAE] v5.0 Grade >1). 5. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months before start of study intervention). 6. Myocardial infarction less than 6 months before the start of study intervention. 7. Uncontrolled hypertension, defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg, despite optimal medical management. 2. Known brain metastases or spinal cord compression. 3. History of myelodysplastic syndrome (MDS)/leukemia. 4. A known additional malignancy that has required active treatment within the past 3 years before the start of study intervention, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinomas in situ that have undergone curative therapy. 5. Current infections requiring systemic therapy or infected non-healing wound. 6. Clinically significant toxicities related to prior anticancer therapies not recovered to ≤ Grade 1 CTCAE v5.0 or that have not returned to baseline. Chronic toxic effects of CTCAE Grade ≤2 from prior anticancer therapy where no further resolution is expected do not require exclusion with agreement between the Investigator and Sponsor (e.g., chemotherapy-induced neuropathy, fatigue, alopecia, anorexia, etc.). 7. Known or expected hypersensitivity or intolerance to the study intervention (including excipients). 8. Known human immunodeficiency virus (HIV) infection without established antiretroviral therapy and control of viral load (more than 400 copies/mL cells/µL) or a history of acquired immunodeficiency syndrome (AIDS) defining opportunistic infection. 9. Known active or symptomatic viral hepatitis. 10. Major surgery (defined as the opening of a body cavity), open biopsy, or significant trauma within 4 weeks before start of study intervention. 11. Any of the following: 1. Prior exposure to any other GRPR-targeting therapeutic agents. 2. Prior treatment with any systemic anticancer therapy including chemotherapy, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the start of study intervention, except luteinizing hormone-releasing hormone (LHRH) or gonadotropin releasing hormone (GnRH) for patients with mCRPC. 3. Prior EBRT completed less than 6 weeks before the start of study intervention. Note that palliative radiotherapy completed less than 6 weeks before the start of study intervention will be allowed if: (i) no more than 10% of the participants' bone marrow is irradiated, (ii) it does not encompass all potential target/measurable lesions. 4. Prior systemic therapeutic radiopharmaceutical treatments. 5. Previous high-dose chemotherapy needing hematopoietic-stem-cell-rescue, or autologous or allogeneic stem-cell transplantation. 6. Prior external beam radiation therapy to more than 25% of the bone marrow. 7. Granulocyte colony-stimulating factor (G-CSF), erythropoietin or transfusions within 4 weeks before start of study intervention. 8. Chronic systemic corticosteroids greater than the equivalent dose of 10 mg of prednisone/ prednisolone per day for at least 4 weeks before the first administration of 212Pb-DOTAM-GRPR1. 12. Any other condition which, in the opinion of the Investigator, would preclude participation in this study. 13. Participants with diabetes inadequately controlled on current treatment as judged by the Investigator or with hyperglycemia ≥ CTCAE Version 5.0 Grade 2. 14. History of or ongoing acute or chronic pancreatitis. 15. Concurrent bladder outflow obstruction or unmanageable urinary incontinence. 16. Female participants who are pregnant or breastfeeding. 17. For participants with mCRPC: Diffuse bone or bone marrow involvement, i.e., a "superscan": defined as bone scans in which there is excessive skeletal radioisotope uptake in relation to soft tissues along with absent or faint activity in the genitourinary tract due to diffuse bone / bone marrow metastases.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05283330
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Orano Med LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cervical Cancer, Prostate Cancer Metastatic, Breast Cancer, Colon Cancer, NSCLC, Cutaneous Melanoma
Additional Details

In this open-label, dose escalation and dose expansion single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study, adult subjects with recurrent or metastatic histologically confirmed GRPR-expressing tumors will be enrolled. In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a TITE Boin design for the MAD cohorts. Dose escalation may proceed until the recommended MAD dose is determined. Up to four (2 SAD and 2 MAD) cohorts are expected to be enrolled. Subjects will be treated with up to four cycles administered every 8 weeks. Once the recommended MAD dose is determined, the expansion cohorts of the study will commence. A dosimetry sub study will also be conducted in which participants will receive a single injection of 203Pb-DOTAM-GRPR1 with 1 week follow-up.

Arms & Interventions

Arms

Experimental: ²¹²Pb-DOTAM-GRPR1

In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a TITE Boin design for the MAD cohorts. Doses will be increased by approximately 30% in subsequent cohorts. The maximum total dose that may be administered to a subject per cycle is 6.0 mCi +/- 10%. The maximum total dose that may be administered to a subject in the MAD regimen is 24 mCi over 4 cycles.

Interventions

Drug: - ²¹²Pb-DOTAM-GRPR1

²¹²Pb-DOTAM-GRPR1 is a radioimmunoconjugate comprised of ²¹²Pb, the metal chelator DOTAM (1,4,7,10-Tetrakis(carbamoylmethyl)-1,4,7,10- tetraazacyclododecane) and a GRPR-targeted antagonist.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Recruiting

Address

Northwestern University Robert H Lurie Medical Research

Chicago, Illinois, 60611

Site Contact

[email protected]

469-638-0744

UK Markey Cancer Center, Lexington, Kentucky

Status

Recruiting

Address

UK Markey Cancer Center

Lexington, Kentucky, 40536

Site Contact

[email protected]

859-323-7628

Advanced Molecular Imaging and Therapy, Glen Burnie, Maryland

Status

Recruiting

Address

Advanced Molecular Imaging and Therapy

Glen Burnie, Maryland, 21061

Site Contact

[email protected]

443-333-1894

XCancer Omaha / Urology Cancer Center, Omaha, Nebraska

Status

Recruiting

Address

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, 68130

Site Contact

[email protected]

402-697-2229

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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