A Phase 1/2 interventional study of CRB-701 and Anti-PD-1 in Solid Tumor, Adult, sponsored by Corbus Pharmaceuticals Inc.. Recruiting at 41 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Corbus Pharmaceuticals Inc. · Phase 1/2, Interventional, and Treatment
The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.
The main questions it aims to answer are:
What is the the safe and effective dose of CRB-701? What cancers can be treated effectively with CRB-701?
Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.
This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4.
Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT.
Part B will evaluate two dose levels of CRB-701 alone and in combination with anti-PD-1 by using a time-to-event Bayesian optimal Phase 2 study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors.
During Part C, the recommended dose level of CRB-701 for further exploration defined in Part B will explore CRB-701 alone or combined with anti-PD-1 in up to seven separate cohorts of participants with advanced tumors known to express Nectin-4.
Corbus Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1
Drug: CRB-701
CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1
Drug: CRB-701
CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1
Drug: CRB-701
CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1
Drug: CRB-701
Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1
Drug: CRB-701
Selected Low dose of CRB-701, intravenous infusion over 30 mins
Drug: CRB-701
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
Drug: CRB-701 · Drug: Anti-PD-1
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
Drug: CRB-701
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
Drug: CRB-701 · Drug: Anti-PD-1
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
Drug: CRB-701
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
Drug: CRB-701 · Drug: Anti-PD-1
Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1
Drug: CRB-701 · Drug: Anti-PD-1
Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1
Drug: CRB-701 · Drug: Anti-PD-1
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
Drug: CRB-701
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
Drug: CRB-701 · Drug: Anti-PD-1
Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701
Occurrence of Dose Limiting Toxicities as defined in the protocol
Time frame: 21 days
Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR)
ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1
Time frame: Up to 6 months
Parts A, B, & C: To characterize the safety profile of CRB-701
Numbers of treatment emergent adverse events with severity determined using NCI CTCAE v5.0 after single or multiple doses of CRB-701 or single and multiple doses of CRB-701 and an anti-PD-(L)1 therapy
Time frame: Up to 6 months
Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax)
Maximum observed plasma concentration of total ADC after single and multiple doses
Time frame: Approximately 9 weeks
Maximum observed plasma concentration of free MMAE (Cmax)
Maximum observed plasma concentration of free MMAE after single and multiple doses
Time frame: Approximately 9 weeks
Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR)
DCR is the sum of percentage of participants meeting the definition of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 4 months using RECIST 1.1
Time frame: Up to 6 months
Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax)
Maximum observed plasma concentration of free MMAE after single and multiple doses
Time frame: Approximately 9 weeks
Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax)
The amount of time to reach Cmax after single and multiple dose administration of CRB-701 (Total ADC)
Time frame: Approximately 9 weeks
Time to reach Cmax of free MMAE (Tmax)
The amount of time to reach Cmax after single and multiple dose administration of free MMAE
Time frame: Approximately 9 weeks
Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax)
The amount of time to reach Cmax after single and multiple dose administration of Tab
Time frame: Approximately 9 weeks
Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax)
Maximum observed plasma concentration of free MMAE after single and multiple doses
Time frame: Approximately 9 weeks
Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC)
Maximum observed plasma concentration of free MMAE after single and multiple doses
Time frame: Approximately 9 weeks
Total Area Under the plasma concentration-time curve of free MMAE (AUC)
Area under the plasma concentration versus time curve after single and multiple dose administration of free MMAE
Time frame: Approximately 9 weeks
Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC)
Area under the plasma concentration versus time curve after single and multiple dose administration of Tab
Time frame: Approximately 9 weeks
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Plan to share: No
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Started Apr 2024 (actual). Primary completion is estimated for Jan 2027, 33 months after the start.
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Studies of the drug tested here: Sutantatug Envedotin
Corbus Pharmaceuticals Inc.