Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

156

participants targeted

Target at P75+ for phase_1

Timeline

7mo left

Started Dec 2024

Typical duration for phase_1

Geographic Reach

2 countries

26 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Progress72%

Dec 2024Dec 2026

First Submitted

Initial submission to the registry

September 13, 2024

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

September 13, 2024

Last Update Submit

May 29, 2025

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

Occurance of Dose-limiting toxicities
28 days
Characterize the safety of CRB-601 in combination anti-PD(L)1 therapy
Incidence of treatment emergent adverse events and clinically significant changes in laboratory parameters, ECG, vital signs and physical exam findings over treatment duration
6 months
To evaluate the efficacy of CRB-601 in terms of DCR when administered in combination with anti-PD(L)-1
Disease Control Rate (Complete Responses plus Partial Responses plus Stable Disease for at least 4 months as determined by the Investigator using RECIST 1.1.
6 months

Secondary Outcomes (3)

To evaluate the preliminary antitumor activity of CRB-601 in combination with anti-PD(L)1 therapy
6 months
To characterize the PK profile of CRB-601
28 Days
To characterize the PK profile of CRB-601
28 Days

Study Arms (8)

Part A: Dose 1 CRB-601 monotherapy

EXPERIMENTAL

Dose 1 of CRB-601 (3mg/Kg) administered intravenously every two weeks

Drug: CRB-601 monoclonal antibody

Part A: Dose 2 of CRB-601 monotherapy

EXPERIMENTAL

Dose 2 of CRB-601 (10mg/Kg) administered intravenously every two weeks

Drug: CRB-601 monoclonal antibody

Part A: Dose 3 of CRB-601 monotherapy

EXPERIMENTAL

Dose 3 of CRB-601 (30mg/Kg) administered intravenously every two weeks

Drug: CRB-601 monoclonal antibody

Part B/Cohort 1: Dose level (low) CRB-601 in combination with anti-PD(L)-1

EXPERIMENTAL

Dose (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed as per label.