A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients With Relapsed or Refractory Advanced Solid Tumors

Plain English Summary

Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors is a Phase 1 clinical trial sponsored by ImmunoGenesis studying Solid Tumor. This trial tests a new drug called IMGS-001 for advanced solid tumors that haven't responded to other treatments. It is for patients with specific types of advanced solid tumors, including ovarian, colorectal, lung, nasopharyngeal, and head and neck/cervical cancers. Participation involves receiving the study drug, IMGS-001, and undergoing regular medical check-ups and tests. Alternative treatments may include standard chemotherapy, targeted therapy, or other immunotherapies, depending on the specific cancer type and prior treatments. The trial aims to enroll 105 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced solid tumors that have spread or returned after standard treatment. Specific tumor types are eligible, including ovarian, colorectal (with certain markers), non-small cell lung, nasopharyngeal, and head and neck/cervical cancers. Patients must have a good general health status (ECOG 0-1) and a life expectancy of over 3 months. Individuals who have had certain prior cancer therapies, especially immunotherapies, may have specific eligibility requirements or exclusions. This trial is studying Solid Tumor, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will determine how safe IMGS-001 is and what the best dose is for future studies, helping doctors understand if the drug can be safely given to patients. The specific primary outcome measures are: Phase 1a- Safety and tolerability of IMGS-001 by 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) (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial explores a new treatment option for patients with advanced solid tumors that have resisted current therapies, addressing a significant unmet need in cancer treatment. This research targets Solid Tumor, where improved treatment options are needed.

Investor Insight

This Phase 1 trial represents an early-stage investment in a novel cancer therapy, with potential for significant market impact if successful in treating difficult-to-treat solid tumors. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific tumor types being studied and if your cancer fits the criteria. Understand the schedule of visits, tests, and potential side effects associated with IMGS-001. Discuss how this trial fits with other treatment options you may have considered or are currently receiving. This trial is currently recruiting participants. The trial is being conducted at 6 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 105 participants

Interventions

• DRUG: IMGS-001 — Every 2 weeks

Primary Outcomes

• Phase 1a- Safety and tolerability of IMGS-001 by 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) (12 months)

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion Criteria:

* 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:

  1. 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.
  2. 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.
  3. 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).
  4. 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).
  5. 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:

  1. Received at least 2 doses of an approved or investigational anti PD-1 or anti-PD-L1 inhibitor.
  2. Last dose of therapy must have been ≥ 28 days prior to Cycle 1 Day 1.
  3. 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.
* Life expectancy \> 3 months.
* At least one measurable lesion as defined by RECIST 1.1.

  a. A lesion that was previously irradiated may be considered a target lesion only if it is measurable per RECIST 1.1, has documented progression, and is clearly defined.
* Patients must have a non-target lesion that can be biopsied. If a patient only has one target lesion (and no non-target lesions) the target lesion used for biopsy must be ≥ 2 cm in longest diameter. Eligible subjects for biopsy must be clinically appropriate, including specimens attainable and on appropriate subjects without presenting high risk of major complications. Subjects who are unable to undergo a biopsy at screening must submit archival tumor tissue retrieved within the last 6 months.
* Patients must have adequate bone marrow and organ function as defined by:

  1. Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L.
  2. Platelet count of ≥ 100.0×10\^9/L.
  3. Hemoglobin of ≥ 9.0 g/dL.
  4. Creatinine clearance ≥ 30 mL/min.
  5. Liver function test: AST (SGOT) and ALT (SGPT) ≤ 2.5 times the institutional ULN.
  6. Total bilirubin: ≤ 1.5 x ULN.

Exclusion Criteria:

* 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 

Trial Locations

• Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
• Sarcoma Oncology Center, Santa Monica, California, United States
• St. Elizabeth Healthcare, Edgewood, Kentucky, United States
• Ochsner Clinic Foundation, New Orleans, Louisiana, United States
• MD Anderson Cancer Center, Houston, Texas, United States
• NEXT Dallas, Irving, Texas, United States

Frequently Asked Questions

Related Conditions

• Solid Tumor
• Ovarian Cancer
• Colorectal Cancer
• Non-Small Cell Lung Cancer
• Nasopharyngeal Cancer
• Head and Neck Cancer
• Cervical Cancer
• Metastatic Cancer
• Relapsed Cancer
• Refractory Cancer

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