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

ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorbus Pharmaceuticals Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy.

Disqualifiers

Active of uncontrolled CNS metastases

History of solid tumors other than the diseases under study

History of and/or current cardiovascular events or conditions in the previous 6 months

Pre-existing >/= Grade 2 neuropathy

Trial design

Design model

Sequential

Treatments tested in this trial

  • CRB-701

    Drug

    Nectin-4 targeted Antibody Drug Conjugate (ADC)

  • Anti-PD-1

    Drug

    checkpoint inhibitor

Treatment groups

348 Participants
are divided into 15 treatment groups

15

Treatment groups

See each treatment group below.

Group A: Part A Dose Escalation - CRB-701 Dose Level 1Experimental treatment 1 intervention
Group B: Part A Dose Escalation - CRB-701 Dose Level 2Experimental treatment 1 intervention
Group C: Part A Dose Escalation - CRB-701 Dose Level 3Experimental treatment 1 intervention
Group D: Part A Dose Escalation - CRB-701 Dose Level 4Experimental treatment 1 intervention
Group E: Part B Dose Optimization: CRB-701 High doseExperimental treatment 1 intervention
Group F: Part B Dose Optimization: CRB-701 low doseExperimental treatment 1 intervention
Group G: Part C Dose Expansion - Cohort 1Experimental treatment 2 interventions
Group H: Part C Dose Expansion - Cohort 2Experimental treatment 1 intervention
Group I: Part C Dose Expansion - Cohort 3Experimental treatment 2 interventions
Group J: Part C Dose Expansion - Cohort 4Experimental treatment 1 intervention
Group K: Part C Dose Expansion - Cohort 5Experimental treatment 2 interventions
Group L: Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1Experimental treatment 2 interventions
Group M: Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1Experimental treatment 2 interventions
Group N: Part C Dose Expansion - Cohort 6Experimental treatment 1 intervention
Group O: Part C Dose Expansion - Cohort 7Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corbus Pharmaceuticals Inc.

Lead sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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