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IMGS-001 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by ImmunoGenesis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients participating in Part 2 (Phase 1b) must have confirmed PD-L1 positive expression (CPS ≥ 5 or TPS ≥ 5%).

- Colorectal: Failed or intolerant to prior lines of appropriate standard of care chemotherapy and targeted therapy regimens. Must be naïve to treatment with PD-1 and PD-L1 targeting agents.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test the safety & effectiveness of a new drug to treat advanced cancer that has not improved with other treatments.

Who is the study for?

Adults with advanced solid tumors that have worsened after standard treatments can join this trial. They must have a specific type of tumor, adequate organ function, and no recent vaccines or other cancer therapies. People with certain blood counts, liver functions, and those who haven't had severe reactions to PD-1 or PD-L1 inhibitors may qualify.Check my eligibility

What is being tested?

The trial is testing IMGS-001's safety at different doses for treating advanced solid tumors. Phase 1a finds the safest dose levels; Phase 1b tests these doses' effectiveness in select cancers with confirmed PD-L1 positive expression.See study design

What are the potential side effects?

Potential side effects are not detailed here but generally could include typical drug-related reactions such as fatigue, nausea, allergic responses, and possibly unique effects related to IMGS-001 which will be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer tests positive for PD-L1.

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My colorectal cancer has not responded to standard treatments, but I haven't tried PD-1 or PD-L1 inhibitors.

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I am on hormone therapy or have had surgery to lower testosterone for my prostate cancer.

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My kidneys are functioning well enough to clear waste.

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I have received at least 2 doses of a PD-1 or PD-L1 inhibitor.

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I am fully active or can carry out light work.

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My cancer has spread and worsened after standard treatments.

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My triple-negative breast cancer has not responded to standard treatments or immune therapy.

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My bladder cancer did not respond to or I couldn't tolerate standard treatments and immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1a- Safety and tolerability of IMGS-001 by dose-limiting toxicities and adverse events

Phase 1b- Recommended Phase 2 dose (RP2D) of IMGS-001 for specified tumor-specific cohorts as a pharmacologically optimal dose (POD)

Secondary outcome measures

Efficacy of IMGS-001 by Clinical Benefit Rate (CBR)

Efficacy of IMGS-001 by Duration of Response (DOR)

Efficacy of IMGS-001 by Objective Response Rate (ORR) via RECIST 1.1 and iRECIST

+8 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 1b Triple-negative Breast CancerExperimental Treatment1 Intervention

IMGS-001 will be administered every 2 weeks at the highest of the two doses of IMGS-001 that were selected for further evaluation in Phase 1a. Based on meeting minimum prespecified efficacy criteria, additional subjects may be enrolled and randomly assigned (1:1) to receive either the higher dose (Arm A) or a lower dose (Arm B) selected from Phase 1a.

Group II: Phase 1b Ovarian CancerExperimental Treatment1 Intervention

Group III: Phase 1b Gastric or Esophageal CancerExperimental Treatment1 Intervention

Group IV: Phase 1b Colorectal CancerExperimental Treatment1 Intervention

Group V: Phase 1b Bladder CancerExperimental Treatment1 Intervention

Group VI: Phase 1a Solid TumorsExperimental Treatment1 Intervention

IMGS-001 will be administered in escalating doses, with a starting dose of 0.3 mg/kg every 2 weeks escalating up to a maximum dose of 15 mg/kg.

0 / 9Eligibility criteria met

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Who is running the clinical trial?

ImmunoGenesisLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Phase 1a Solid Tumors been granted authorization by the FDA?

"With limited data to suggest efficacy or safety, Phase 1a Solid Tumors received a score of 1."

Answered by AI

Are current participants being accepted for this research project?

"Affirmative. Clinicaltrials.gov has data which attests to the fact that this clinical trial, posted on August 1st 2023 and updated since then, is actively seeking 105 participants from a single medical centre."

Answered by AI

What is the aggregate figure of participants involved in this research endeavor?

"Affirmative. Clinicaltrials.gov's records demonstrate that this study, which was initially launched on August 1st 2023, is actively searching for participants. The trial requires 105 volunteers from one medical facility to take part in the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors

2023. "Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014502.