First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.

Conditions

• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CRB-601 monoclonal antibody — DRUG
  CRB-601
• Anti-PD-1 monoclonal antibody — DRUG
  Anti-PD(L)-1 used as per label

Study Details

The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein. Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer. Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy. There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.

Key Dates

Start date

Dec 4, 2024

Status verified

May 2025

Primary completion

Nov 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

156 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Dose 1 CRB-601 monotherapy
  Dose 1 of CRB-601 (3mg/Kg) administered intravenously every two weeks
• Experimental: Part A: Dose 2 of CRB-601 monotherapy
  Dose 2 of CRB-601 (10mg/Kg) administered intravenously every two weeks
• Experimental: Part A: Dose 3 of CRB-601 monotherapy
  Dose 3 of CRB-601 (30mg/Kg) administered intravenously every two weeks
• Experimental: Part B/Cohort 1: Dose level (low) CRB-601 in combination with anti-PD(L)-1
  Dose (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed as per label.
• Experimental: Part B/Cohort 2: Dose level (high) CRB-601 in combination with anti-PD(L)-1
  High dose CRB-601 (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label.
• Experimental: Part B/Expansion: Dose level (defined in Part B/ Safety Le) CRB-601 in combination with anti-PD(L)-1
  Dose (defined in Part B/ Safety Lead-In) or CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label.
• Experimental: Part C - Low dose CRB-601 in combination with anti-PD(L)-1
  Participants will receive a low dose of CRB-601 (defined in Part A \&B) in combination with standard of care dose of anti-PD(L)-1 therapy.
• Experimental: Part C - High dose CRB-601 in combination with anti-PD(L)-1
  Participants will receive a high dose of CRB-601 (defined in Part A \&B) in combination with standard of care dose of anti-PD(L)-1 therapy.

Primary Outcome Measure

Occurance of Dose-limiting toxicities [ Time Frame: 28 days ]

Central Contacts

• Ian Hodgson, PhD
  617-963-0100
  [email protected]

Locations (20)

Find similar trials in Birmingham, AL

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