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

NCT06014502 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IMGS-001-011
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this Phase 1a/1b clinical trial is to test the safety of an investigational drug called IMGS-001 and to determine how well it can work in treating patients with advanced solid tumors that have come back or are not improving after receiving other drugs that are commonly used for their cancer. Phase 1a (Part 1) will test the safety of five different doses of IMGS-001 to use in further studies. Patients with cancer that have advanced or spread to other parts of the body following treatment with other available therapies will be treated in Part 1. Phase 1b (Part 2) will test two doses of IMGS-001 identified in Part 1 to further determine the safety and potential effectiveness in select cancer types.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

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

  Frequency and severity of dose limiting toxicities and adverse events

  21 days

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

  RP2D will be defined by pooling all available PK, PD, target engagement, efficacy, safety, and tolerability data from Part 1 and Part 2

  12 months

Secondary Outcomes (11)

• Phase 1a- Maximum tolerable dose (MTD) of IMGS-001

  12 months

• Pharmacokinetics (PK) of IMGS-001 by terminal half life (t1/2)

  12 months

• Pharmacokinetics of IMGS-001 by Area Under the Curve (AUC)

  12 months

• Pharmacokinetics of IMGS-001 by Maximum Observed Concentration (Cmax)

  12 months

• Pharmacokinetics of IMGS-001 by Minimum Observed Concentration (Cmin)

  12 months

Study Arms (6)

Phase 1a Solid Tumors

EXPERIMENTAL

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 20 mg/kg.

Drug: IMGS-001

Phase 1b Ovarian Cancer

EXPERIMENTAL

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.

Drug: IMGS-001

Phase 1b Colorectal Cancer (Microsatellite Stable; PD-L1 Positive [CPS ≥ 5 or TPS ≥ 5%])

EXPERIMENTAL

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.

Drug: IMGS-001

Phase 1b Non-small Cell Lung Cancer (EGFR Wild-type)

EXPERIMENTAL

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.

Drug: IMGS-001

Phase 1b Nasopharyngeal Cancer

EXPERIMENTAL

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.

Drug: IMGS-001

Phase 1b Head and Neck/Cervical Cancer (HPV positive)

EXPERIMENTAL

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.

Drug: IMGS-001

Interventions

IMGS-001 DRUG

Every 2 weeks

Phase 1a Solid Tumors; Phase 1b Colorectal Cancer (Microsatellite Stable; PD-L1 Positive [CPS ≥ 5 or TPS ≥ 5%]); Phase 1b Head and Neck/Cervical Cancer (HPV positive); Phase 1b Nasopharyngeal Cancer; Phase 1b Non-small Cell Lung Cancer (EGFR Wild-type); Phase 1b Ovarian Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1 Dose-escalation: Patients must have histologically confirmed locally advanced, or metastatic solid tumors who have progressed after receiving appropriate lines of standard therapy known to potentially confer clinical benefit.
• Part 2 Dose-expansion: Patients must have histologically confirmed locally advanced, or metastatic cancer in one of the following pre-specified tumor types and meet tumor-specific criteria:
• Ovarian: Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Must be naïve to treatment with PD-1 and PD-L1 targeting agents.
• Colorectal (microsatellite stable; PD-L1 positive \[CPS ≥ 5 or TPS ≥ 5%\]): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Must be naïve to treatment with PD-1 and PD-L1 targeting agents.
• Non-small cell lung (EGFR wild-type): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-1).
• Nasopharyngeal: Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-L1).
• Head and neck/cervical (HPV positive): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-L1).
• Prostate cancer patients enrolled in Part 1 dose escalation must continue ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analog or have undergone a bilateral orchiectomy (surgical or medical castration) and must have a serum testosterone ≤1.73 nmol/L (50 ng/dL) at screening.
• Patients eligible to enroll in cohorts with prior immune checkpoint therapy must meet the following criteria:
• Received at least 2 doses of an approved or investigational anti PD-1 or anti-PD-L1 inhibitor.
• Last dose of therapy must have been ≥ 28 days prior to Cycle 1 Day 1.
• Eligible patients include those patients treated with anti PD-1/anti PD-L1 drugs who have progressed following response to prior therapy, and those that have failed to demonstrate any response to prior therapy.
• Colorectal patients participating in Part 2 (Phase 1b) must have confirmed PD-L1 positive expression (CPS ≥ 5 or TPS ≥ 5%) using local laboratory results based on prior results obtained within 6 months of baseline, expression testing done on archived tissue within 6 calendar months of baseline, or fresh biopsy.
• Male or female ≥ 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

You may not qualify if:

• Receipt of any investigational or conventional anti-cancer drug/therapy within 21 days of Cycle 1 Day 1.
• Current or prior use of immunosuppressive medication within 14 days of Cycle 1 Day 1. Inhaled and intranasal corticosteroids are allowed.
• Current or prior use of interleukin-2, interferon, or other immunotherapy medication within 28 days of Cycle 1 Day 1.
• Live vaccine within 28 days prior to Cycle 1 Day 1.
• Any toxicity from prior standard therapy that has not resolved to ≤ Grade 1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 at the time of consent. Alopecia is an exception. Any patients with irreversible Grade 1 or Grade 2 toxicities that are considered stable may be enrolled after discussion with the Medical Monitor.
• Prior anti-PD-1 or anti-PD-L1-related Grade 3 or Grade 4 toxicity resulting in treatment discontinuation of the drug.
• Secondary malignancy other than the target malignancy to be investigated in this trial within the last 2 years.
• History of myocardial infarction, ischemic heart disease, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III IV), or significant cardiac arrhythmias within 3 months of study enrollment.
• Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) or pulmonary embolism within 3 months of study enrollment.
• History of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis, bowel perforation, or other known risk factors for bowel perforation.
• Active, uncontrolled, or prior documented autoimmune disorders including but not limited to inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, systemic sclerosis (scleroderma), Systemic Lupus Erythematosus, or autoimmune vasculitis (e.g., Wegener's Granulomatosis). Alopecia, vitiligo, celiac disease controlled by diet, and chronic skin conditions not requiring systemic therapy/immunosuppressive treatment is permitted.
• Uncontrolled intercurrent illness, including active infection requiring systemic therapy, uncontrolled hypertension (\> 150/90mm Hg despite optimal medical management), uncontrolled asthma, psychiatric illness/social situations, substance abuse, or other underlying medical conditions that would limit compliance with study requirements, obscure the interpretation of AEs, substantially increase the risk of developing AEs, or make the administration of study treatment hazardous.
• Active human immunodeficiency virus (HIV) infection (Exception: patients with well-controlled HIV \[e.g., CD4 ≥ 350 cells/uL and undetectable viral load\] who have been on an effective \[drug, dosage, and schedule associated with reduction and control of the viral load\] antiretroviral therapy \[ART\] for ≥ 4 weeks are eligible). Patients with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last 12 months are not eligible.
• Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with a history of HCV infection must have completed curative antiviral treatment and must have a viral load below the limit of quantification. A patient who is HCV antibody (Ab) positive but HCV RNA negative due to prior treatment or natural resolution is eligible.
• History of solid organ transplantation.

Sponsors & Collaborators

• ImmunoGenesis: lead

Study Sites (5)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Dallas

Irving, Texas, 75039, United States

RECRUITING

Central Study Contacts

Charles Schweizer, PhD

CONTACT

346-772-0336; charles.schweizer@immunogenesis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 28, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)