CRB-701 for Cancer

Recruiting at 55 trial locations

Overseen By Ian Hodgson, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Corbus Pharmaceuticals Inc.

Disqualifiers: CNS metastases, Cardiovascular events, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

348 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CRB-701 (also known as SYS-6002) for individuals with solid tumors that express a specific protein called nectin-4. The main goal is to determine the safest and most effective dose of CRB-701 and identify which cancer types respond well to it. Participants will receive CRB-701 through an IV and may also receive another drug called anti-PD-1. Individuals with advanced or metastatic nectin-4 expressing tumors who have not had success with other treatments might be suitable candidates. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial group, offering participants a chance to be among the first to benefit from this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that CRB-701 is generally well-tolerated by patients with advanced solid tumors that express the protein nectin-4. In a previous study with 70 participants, researchers examined safety data and found encouraging results. Most patients did not experience severe side effects, indicating a promising safety profile.

Another report demonstrated that CRB-701 not only helped fight tumors but was also well-tolerated by patients. This suggests the treatment is both effective and safe. It targets the protein nectin-4, often found in certain cancer cells.

Overall, studies so far suggest that CRB-701 has positive safety results, making it a potentially safe option for treating specific cancers. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cancer?

Researchers are excited about CRB-701 because it targets cancer cells differently than many existing treatments. While many standard cancer therapies, like chemotherapy, attack both healthy and cancerous cells, CRB-701 is designed to be more precise. It uses a targeted approach by combining with anti-PD-1, a type of immunotherapy that helps the immune system recognize and attack cancer cells more effectively. This combination could potentially improve effectiveness and reduce side effects compared to conventional treatments.

What evidence suggests that CRB-701 could be an effective treatment for cancer?

Research has shown that CRB-701, which participants in this trial may receive, may effectively treat certain cancers. In head and neck squamous cell carcinoma (HNSCC), it helped nearly 48% of patients. For cervical cancer, it benefited 37.5% of patients, and for metastatic urothelial carcinoma (mUC), it aided 55.6% of patients. The treatment has been well-tolerated, generally causing few side effects. CRB-701 has also received FDA fast track designation for cervical cancer, indicating its potential to meet important medical needs. ^{2 6 7 8 9}

Who Is on the Research Team?

Ari Rosenberg, MD

Principal Investigator

University of Chicago

David Pinato, MD

Principal Investigator

Imperial College London

Ian Hodgson, PhD

Principal Investigator

Corbus International Ltd

Are You a Good Fit for This Trial?

This trial is for individuals with solid tumors that have a protein called nectin-4. Participants will need to visit the clinic for intravenous infusions and undergo blood tests, CT or MRI scans to monitor effects on their tumors.

Inclusion Criteria

My cancer expresses nectin-4 and has worsened after treatment or has no other treatment options.

Exclusion Criteria

I have brain metastases that are not currently under control.

I have had cancer types other than the one currently being studied.

I have moderate to severe nerve damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A involves dose escalation to determine the maximum tolerated dose (MTD) of CRB-701 using the Bayesian optimal interval design.

21 days

Multiple visits for dose administration and monitoring

Dose Optimization

Part B involves determining the recommended Phase 2 dose (RP2D) of CRB-701 by evaluating two dose levels in separate cohorts.

Up to 6 months

Regular visits for dose administration and assessments

Dose Expansion

Part C involves evaluating the RP2D dose of CRB-701 in five planned expansion cohorts using Simon's optimal two-stage design.

Up to 6 months

Regular visits for dose administration and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CRB-701

Trial Overview The study is testing CRB-701 in patients with solid tumors. It aims to determine the safe and effective dosage of CRB-701 when administered alone and its effectiveness against various cancers.

How Is the Trial Designed?

Group I: Part C Dose Expansion - Cohort 7 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group II: Part C Dose Expansion - Cohort 6 Experimental Treatment 1 Intervention

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins

Group III: Part C Dose Expansion - Cohort 5 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group IV: Part C Dose Expansion - Cohort 4 Experimental Treatment 1 Intervention

Recommended Phase 2 dose of CRB-701 and schedule, intravenous infusion over 30 mins

Group V: Part C Dose Expansion - Cohort 3 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group VI: Part C Dose Expansion - Cohort 2 Experimental Treatment 1 Intervention

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins

Group VII: Part C Dose Expansion - Cohort 1 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group VIII: Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1 Experimental Treatment 2 Interventions

Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group IX: Part B Dose Optimization: CRB-701 low dose Experimental Treatment 1 Intervention

Selected Low dose of CRB-701, intravenous infusion over 30 mins

Group X: Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1 Experimental Treatment 2 Interventions

Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group XI: Part B Dose Optimization: CRB-701 High dose Experimental Treatment 1 Intervention

Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1

Group XII: Part A Dose Escalation - CRB-701 Dose Level 4 Experimental Treatment 1 Intervention

CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1

Group XIII: Part A Dose Escalation - CRB-701 Dose Level 3 Experimental Treatment 1 Intervention

CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1

Group XIV: Part A Dose Escalation - CRB-701 Dose Level 2 Experimental Treatment 1 Intervention

CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1

Group XV: Part A Dose Escalation - CRB-701 Dose Level 1 Experimental Treatment 1 Intervention

CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1

CRB-701 is already approved in United States for the following indications:

Approved in United States as CRB-701 for:

• Relapsed/Refractory Metastatic Cervical Cancer

Who Is Running the Clinical Trial?

Corbus Pharmaceuticals Inc.

Lead Sponsor

Trials

9

Recruited

1,800+

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Industry Sponsor

Trials

19

Recruited

2,500+

Citations

1. ir.corbuspharma.com ir.corbuspharma.com/news-events/press-releases/detail/452/corbus-pharmaceuticals-presents-crb-701-robust-clinical-responses-in-hnscc-and-cervical-cancers-at-esmo25

Corbus Pharmaceuticals Presents CRB-701 Robust ... 3.6 mg/kg dose generated ORR of 47.6% in HNSCC, 37.5% in cervical cancer and 55.6% in mUC · CRB-701 continues to demonstrate a favorable safety ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.807

Phase I dose-escalation study of the next-generation nectin ... CRB-701, a next-generation nectin-4 targeted ADC, has third-generation linker technology that is specifically designed to reduce the dose-limiting toxicities ( ...

3. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-crb-701-in-relapsed-refractory-cervical-cancer

FDA Grants Fast Track Designation to CRB-701 in ... CRB-701 has received FDA fast track designation for the treatment of adult patients with relapsed/refractory metastatic cervical cancer.

4. cancernetwork.com cancernetwork.com/view/fda-grants-fast-track-designation-to-crb-701-in-pretreated-recurrent-hnscc

FDA Grants Fast Track Designation to CRB-701 in ... The next-generation ADC, CRB-701, demonstrated an emerging objective response rate of 57% in a subgroup of patients with HNSCC.

5. ir.corbuspharma.com ir.corbuspharma.com/news-events/press-releases/detail/451/corbus-pharmaceuticals-to-present-crb-701-phase-12-data-at-esmo-2025

Corbus Pharmaceuticals to Present CRB-701 Phase 1/2 ... The poster will present updated data from a September 1st, 2025 data cut on 167 enrolled participants of which 122 participants were evaluable ...

6. ir.corbuspharma.com ir.corbuspharma.com/news-events/press-releases/detail/435/crb-701-sys6002-a-next-generation-nectin-4-targeting-adc-demonstrates-encouraging-safety-and-broader-efficacy-in-phase-1-study-in-the-us-and-uk-presented-at-asco-gu-2025

CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting ... CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3151

Clinical update related to the first-in-human trial of ... SYS6002 (CRB-701) demonstrates promising anti-tumor activity with a well-tolerated safety profile in patients with advanced nectin-4 positive solid tumors.

8. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-crb-701-for-pretreated-recurrent-or-metastatic-hnscc

FDA Grants Fast Track Designation to CRB-701 for ... CRB-701 targets Nectin-4 and has shown promising efficacy in recurrent/metastatic HNSCC, with a 57% objective response rate and 86% disease ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06265727

A Phase 1/2 Study to Investigate CRB-701 in Solid 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 ...