Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

Immunocore

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: HLA-A*02:01-positive; Cancer

Treatments: Drug: Antiangiogenic Agent; Drug: IMC-R117C; Drug: Monoclonal antibody; Drug: Chemotherapy drug; Drug: Kinase inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT06840119

IMC-R117C-1004

2023-508090-87-00 (Other Identifier)

Details and patient eligibility

About

This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A*02:01-positive participants with selected advanced cancers.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• HLA-A*02:01-positive
• Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma
• Archived or fresh tumor tissue sample that must be confirmed as adequate
• Evaluable/Measurable disease per RECIST 1.1
• Previously received applicable standard treatments
• Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control

Exclusion criteria

• Symptomatic or untreated central nervous system metastasis
• Recent bowel obstruction
• Ongoing ascites or effusion requiring recent drainages
• Significant ongoing toxicity from prior anticancer treatment
• Out-of-range laboratory values
• Clinically significant lung, heart, or autoimmune disease
• Ongoing requirement for immunosuppressive treatment
• Significant secondary malignancy
• Hypersensitivity to study drug or excipients
• Pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Arm A: IMC-R117C Monotherapy Dose-Escalation

Experimental group

Description:

Participants receive IMC-R117C intravenous (IV) infusion.

Treatment:

Drug: IMC-R117C

Arm B: IMC-R117C Combination Dose-Escalation

Experimental group

Description:

Participants receive IMC-R117C IV infusion in combination with standard of care chemotherapy and antiangiogenic agent

Treatment:

Drug: Chemotherapy drug

Drug: Chemotherapy drug

Drug: IMC-R117C

Drug: Antiangiogenic Agent

Arm C: IMC-R117C Combination Dose-Escalation

Experimental group

Description:

Participants receive IMC-R117C IV infusion with targeted therapies

Treatment:

Drug: Kinase inhibitor

Drug: Monoclonal antibody

Drug: IMC-R117C

Arm D: Control Arm

Active Comparator group

Description:

Participants receive standard of care chemotherapy and antiangiogenic agent

Treatment:

Drug: Chemotherapy drug

Drug: Chemotherapy drug

Drug: Antiangiogenic Agent