Health TrialsbyHealthPanel

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

ConditionsCancerHLA-A*02:01-positive
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunocore Ltd

About this trial

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 PIWIL1-Positive cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Symptomatic or untreated central nervous system metastasis

Recent bowel obstruction

Ongoing ascites or effusion requiring recent drainages

Significant ongoing toxicity from prior anticancer treatment

Trial design

Design model

Sequential

Treatments tested in this trial

  • IMC-R117C

    Drug

    IV infusion

  • Chemotherapy drug

    Drug

    IV infusion

  • Chemotherapy drug

    Drug

    oral

  • Kinase inhibitor

    Drug

    oral

  • Antiangiogenic Agent

    Drug

    IV infusion

  • Monoclonal antibody

    Drug

    IV infusion

Treatment groups

600 Participants
are divided into 4 treatment groups
Group A: Arm A: IMC-R117C Monotherapy Dose-EscalationExperimental treatment 1 intervention
Group B: Arm B: IMC-R117C Combination Dose-EscalationExperimental treatment 3 interventions
Group C: Arm C: IMC-R117C Combination Dose-EscalationExperimental treatment 3 interventions
Group D: Arm D: Control ArmActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)

Time frame
Up to ~24 months
2

Dose Escalation: Percentage of participants with ≥1 adverse event (AE)

Time frame
Up to ~24 months
3

Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)

Time frame
Up to ~24 months
4

Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings

Time frame
Up to ~24 months

Secondary outcomes

1

Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination

Time frame
Up to ~36 months
2

Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination

Time frame
Up to ~36 months
3

Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination

Time frame
Up to ~36 months
4

Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination

Time frame
Up to ~36 months

Other outcomes

Sponsors and contacts

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

Immunocore Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now