Solid TumorPhase 1NCT06014502
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
A Phase 1 study testing IMGS-001 in people with Solid Tumor, run by ImmunoGenesis at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IMGS-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 13 sitesUnited States
- Study dates
- 7 Sep 2023to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Nasopharyngeal: non-keratinizing; ≤ 2 prior lines of therapy in relapse setting; patients should have received prior chemotherapy and/or immune checkpoint blockade as per SOC.
- 9p24.1 Lymphomas (classic Hodgkin's, PMBCL): post first line therapy and completion of salvage regimens (including ASCT) with curative intent per SOC.
- Ovarian (high-grade epithelial, fallopian tube, or primary peritoneal): platinum resistant disease defined as progression within < 6 months from completion of a platinum-based chemotherapy regimen; platinum refractory subjects are excluded (defined as disease that has recurred/progressed while receiving platinum-based frontline therapy). ≤ 3 prior lines of therapy in relapse setting; may be naive or exposed to prior checkpoint therapy; may have received prior folate receptor alpha (FRα) antibody-drug conjugate (ADC), other targeted therapies, and/or PARPi as appropriate per SOC; confirmed PD-L1 CPS ≥1.
- NSCLC (non-mutated, squamous/non-squamous): ≤ 2 prior lines of therapy in relapse setting; patients could have received prior chemotherapy, immune checkpoint blockade, or targeted therapy in earlier lines of therapy as per SOC; confirmed PD-L1 CPS ≥1 or TPS ≥50%.
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- Head and neck squamous cell carcinoma (HPV+): ≤ 2 prior lines of therapy in relapse setting; patients could have received prior chemotherapy, immune checkpoint blockade, or cetuximab as appropriate per SOC; confirmed PD-L1 CPS≥1.
- 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.
- Ovarian cancer, HNSCC, and NSCLC patients participating in Part 2 (Phase 1b) must have confirmed PD-L1 positive expression (CPS ≥ 1 or TPS ≥ 50% [NSCLC only]).
- Male or female ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy > 3 months.
- At least 1 measurable lesion as defined by RECIST 1.1. Subjects with lymphoma must have measurable disease as per Lugano Criteria (2014).
- 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.
- Patients must have adequate bone marrow and organ function as defined by:
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L.
- Platelet count of ≥ 100.0×10^9/L.
- Hemoglobin of ≥ 9.0 g/dL.
- Creatinine clearance ≥ 30 mL/min.
- Liver function test: AST (SGOT) and ALT (SGPT) ≤ 2.5 times the institutional ULN.
- Total bilirubin: ≤ 1.5 x ULN.
Who cannot join
- 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 except those required in the protocol pre-medication regimen. 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.
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- Secondary malignancy other than the target malignancy to be investigated in this trial within the last 2 years. Subjects with a history of carcinoma in situ, basal cell carcinoma and other malignancies with low risk of recurrence, that have been curatively treated and have not progressed, and are under surveillance may be enrolled.
- 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.
- Newly diagnosed, uncontrolled, and/or untreated cancer-related central nervous system disease. Patients with treated brain metastases that are radiographically or clinically stable for at least 28 days after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible if they are asymptomatic and do not require corticosteroids (the patient must have discontinued steroids at least 14 days prior to Cycle 1 Day 1).
- Major surgery, open biopsy, or significant traumatic injury within 28 days of Cycle 1 Day 1, or still recovering from prior surgery. Port placement and other local procedures are allowed if completed at least 48 hours prior to Cycle 1 Day 1.
- Abnormal pulmonary function within the previous 6 months prior to Cycle 1 Day 1, including history of or active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, recurrent pleural effusion (including malignant origin), severe dyspnea at rest or requiring supplementary oxygen therapy. Subjects with pleural effusions that are small and not clinically significant (e.g. not causing shortness of breath) are eligible with Medical Monitor approval.
- Patients who have experienced any infusion related reaction Grade 3 or higher from prior therapy per NCI CTCAE version 5.0
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Sara McCauley, MSN, RN, 859-301-4245, sara.mccauley@stelizabeth.com
Daniel Flora, MD
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Palee Swisher, RN, BSN, 480-440-7458, BMDACCResearch@Bannerhealth.com
Madappa Kundranda, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Ly Nguyen, 713-563-2169, LMNguyen1@mdanderson.org
David S. Hong, MD
- Recruiting
NEXT Dallas
Irving, Texas, 75039
Erica Torres, (210) 610-5205, etorres@nextoncology.com
Shiraj Sen, MD
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Kristin Steele, RN, 504-842-3929, kristin.steele@ochsner.org
Daniel Johnson, MD
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Amber Ingram, MS, CCRC, 757-262-4633, Amber.Ingram@usoncology.com
Jedrzej Wykretowicz, MD, PhD
- Recruiting
UC Irvine
Orange, California, 92868
Victoria Villaflor, MD, 714-456-5153, ucstudy@hs.uci.edu
Victoria Villaflor, MD
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Shaila Parker, BSN, 215-214-3789, Shaila.parker@fccc.edu
Parth A Desai, MBBS, MD
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Melanie Faulkner, 878-261-6624, Faulknermy2@UPMC.edu
Diwakar Davar, MBBS, MSc
- Recruiting
Sarcoma Oncology Center
Santa Monica, California, 90403
Victoria Chua, 310-552-9999, vchua@sarcomaoncology.com
Neal S. Chawla, MD
- Recruiting
WashU
St Louis, Missouri, 63110
Jessica Ley, 314-747-8092, jcley@wustl.edu
Brendan J Knapp, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Adeline O'Connor, 813-745-5266, adeline.oconnor@moffitt.org
Robin Park, MD
- Recruiting
Texas Oncology
Tyler, Texas, 75702
Jennifer Castner, BSN, RN, 903-535-4687, jennifer.castner@usoncology.com
Donald Richards, MD, PhD
About this study
Official title: 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
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.
Read the detailed description
Part 1 is a Phase 1a, first-in-human, open-label dose-escalation study to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001. The safety, tolerability, PK parameters, and preliminary antitumor activity of IMGS-001 will be assessed in adult patients with advanced solid tumors refractory to appropriate standard of care (SOC) treatments.
Based on the MTD and other information (e.g., tolerability, PK, PD, target engagement), multiple doses of IMGS-001 will be selected for further evaluation. Additional subjects may be backfilled across Phase 1a doses (or other intermediate doses at or below the MAD/MTD) to assure adequate clinical data to support dose optimization and selection of appropriate doses for use in the Phase 1b. Approximately 35 total subjects will be enrolled in Phase 1a.
Part 2 is a Phase 1b, open-label, dose-expansion study of five prespecified tumor cohorts to assess preliminary antitumor activity of IMGS-001 in patients that are refractory or intolerant to other appropriate prior standard therapies. Stage 1 will consist of two separate cohort designs: 4 single-dose cohorts and 1 tumor specific dose optimization cohort in NSCLC.
The 4 single dose Stage 1 cohorts will initially enroll approximately 10 subjects in each of the following cohorts treated with IMGS-001:
- Cohort 1: Ovarian cancer (high-grade epithelial, fallopian tube, or primary peritoneal; PD-L1 positive [CPS ≥1])
- Cohort 2: 9p24.1 lymphomas (classic Hodgkin's, PMBCL)
- Cohort 3: Nasopharyngeal cancer (non-keratinizing)
- Cohort 4: Head and neck squamous cell carcinoma (HPV+, PD-L1 positive [CPS ≥1])
Each cohort will be assessed to meet efficacy criteria to continue into a randomized dose-optimization. Within each cohort that meets prespecified efficacy criteria, the expanded cohorts will have randomly assigned (1:1) subjects to receive one of two doses used in the Phase 1a. Within each Arm, 20 eligible subjects will be treated with the assigned dose of IMGS-001.
For the Stage 1 dose optimization in the NSCLC cohort, approximately 20 subjects will initially be randomized 1:1 to one of two dose arms. If efficacy criteria are met, the cohort may be expanded to randomize approximately 20 additional subjects across these two doses.
- Conditions
- Solid Tumor
- Being tested
- IMGS-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMGS-001Drug
Every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: IMGS-001 |
| Phase 1b Lymphomas | 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. Receives: Drug: IMGS-001 |
| Phase 1b Non-small Cell Lung Cancer | Experimental | IMGS-001 will be administered every 2 weeks at one 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) across the two doses selected from Phase 1a. Receives: 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. Receives: Drug: IMGS-001 |
| Phase 1b Head and Neck 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. Receives: Drug: IMGS-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (11)
Phase 1a- Maximum tolerable dose (MTD) of IMGS-001
Measured: 12 months
Pharmacokinetics (PK) of IMGS-001 by terminal half life (t1/2)
Measured: 12 months
Pharmacokinetics of IMGS-001 by Area Under the Curve (AUC)
Measured: 12 months
Pharmacokinetics of IMGS-001 by Maximum Observed Concentration (Cmax)
Measured: 12 months
Pharmacokinetics of IMGS-001 by Minimum Observed Concentration (Cmin)
Measured: 12 months
Potential immunogenicity of IMGS-001 by measurement of positive anti-drug antibody (ADA) levels
Measured: 12 months
Efficacy of IMGS-001 by Objective Response Rate (ORR) via RECIST 1.1 and iRECIST; Lugano Criteria (2014) will be used for the lymphoma arm.
Measured: 12 months
Efficacy of IMGS-001 by Progression Free Survival (PFS)
Measured: 12 months
Efficacy of IMGS-001 by Duration of Response (DOR)
Measured: 12 months
Efficacy of IMGS-001 by Clinical Benefit Rate (CBR)
Measured: 12 months
Phase 1b- Safety and tolerability of IMGS-001 by frequency and severity of Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start7 Sep 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunoGenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014502
- Sponsor's protocol ID
- IMGS-001-011
- Status last verified
- Apr 2026
- First submitted
- 17 Aug 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06014502
- Acronym / sponsor ID
- IMGS-001-011
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- ImmunoGenesisIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part 1 is a Phase 1a, first-in-human, open-label dose-escalation study to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001. The safety, tolerability, PK parameters, and preliminary antitumor activity of IMGS-001 will be assessed in adult patients with advanced solid tumors refractory to appropriate standard of care (SOC) treatments.
Based on the MTD and other information (e.g., tolerability, PK, PD, target engagement), multiple doses of IMGS-001 will be selected for further evaluation. Additional subjects may be backfilled across Phase 1a doses (or other intermediate doses at or below the MAD/MTD) to assure adequate clinical data to support dose optimization and selection of appropriate doses for use in the Phase 1b. Approximately 35 total subjects will be enrolled in Phase 1a.
Part 2 is a Phase 1b, open-label, dose-expansion study of five prespecified tumor cohorts to assess preliminary antitumor activity of IMGS-001 in patients that are refractory or intolerant to other appropriate prior standard therapies. Stage 1 will consist of two separate cohort designs: 4 single-dose cohorts and 1 tumor specific dose optimization cohort in NSCLC.
The 4 single dose Stage 1 cohorts will initially enroll approximately 10 subjects in each of the following cohorts treated with IMGS-001:
- Cohort 1: Ovarian cancer (high-grade epithelial, fallopian tube, or primary peritoneal; PD-L1 positive [CPS ≥1])
- Cohort 2: 9p24.1 lymphomas (classic Hodgkin's, PMBCL)
- Cohort 3: Nasopharyngeal cancer (non-keratinizing)
- Cohort 4: Head and neck squamous cell carcinoma (HPV+, PD-L1 positive [CPS ≥1])
Each cohort will be assessed to meet efficacy criteria to continue into a randomized dose-optimization. Within each cohort that meets prespecified efficacy criteria, the expanded cohorts will have randomly assigned (1:1) subjects to receive one of two doses used in the Phase 1a. Within each Arm, 20 eligible subjects will be treated with the assigned dose of IMGS-001.
For the Stage 1 dose optimization in the NSCLC cohort, approximately 20 subjects will initially be randomized 1:1 to one of two dose arms. If efficacy criteria are met, the cohort may be expanded to randomize approximately 20 additional subjects across these two doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Solid Tumors | Experimental | Drug: IMGS-001IMGS-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. |
| Phase 1b Ovarian Cancer | Experimental | Drug: IMGS-001IMGS-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. |
| Phase 1b Lymphomas | Experimental | Drug: IMGS-001IMGS-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. |
| Phase 1b Non-small Cell Lung Cancer | Experimental | Drug: IMGS-001IMGS-001 will be administered every 2 weeks at one 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) across the two doses selected from Phase 1a. |
| Phase 1b Nasopharyngeal Cancer | Experimental | Drug: IMGS-001IMGS-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. |
| Phase 1b Head and Neck Cancer (HPV positive) | Experimental | Drug: IMGS-001IMGS-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- Patients eligible to enroll in cohorts with prior immune checkpoint therapy must meet the following criteria:
- Ovarian cancer, HNSCC, and NSCLC patients participating in Part 2 (Phase 1b) must have confirmed PD-L1 positive expression (CPS ≥ 1 or TPS ≥ 50% [NSCLC only]).
- Male or female ≥ 18 years of age.
Key exclusion criteria (19 listed)
- 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 except those required in the protocol pre-medication regimen. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMGS-001Every 2 weeks | Drug | Phase 1a Solid Tumors, Phase 1b Head and Neck Cancer (HPV positive), Phase 1b Lymphomas, Phase 1b Nasopharyngeal Cancer, Phase 1b Non-small Cell Lung Cancer, Phase 1b Ovarian Cancer |
Primary outcome
Phase 1a- Safety and tolerability of IMGS-001 by dose-limiting toxicities and adverse events
Time frame: 21 days
Frequency and severity of 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)
Time frame: 12 months
RP2D will be defined by pooling all available PK, PD, target engagement, efficacy, safety, and tolerability data from Part 1 and Part 2
11 secondary outcomes
Phase 1a- Maximum tolerable dose (MTD) of IMGS-001
Time frame: 12 months
Pharmacokinetics (PK) of IMGS-001 by terminal half life (t1/2)
Time frame: 12 months
Pharmacokinetics of IMGS-001 by Area Under the Curve (AUC)
Time frame: 12 months
Pharmacokinetics of IMGS-001 by Maximum Observed Concentration (Cmax)
Time frame: 12 months
Pharmacokinetics of IMGS-001 by Minimum Observed Concentration (Cmin)
Time frame: 12 months
Potential immunogenicity of IMGS-001 by measurement of positive anti-drug antibody (ADA) levels
Time frame: 12 months
Efficacy of IMGS-001 by Objective Response Rate (ORR) via RECIST 1.1 and iRECIST; Lugano Criteria (2014) will be used for the lymphoma arm.
Time frame: 12 months
Efficacy of IMGS-001 by Progression Free Survival (PFS)
Time frame: 12 months
Efficacy of IMGS-001 by Duration of Response (DOR)
Time frame: 12 months
Efficacy of IMGS-001 by Clinical Benefit Rate (CBR)
Time frame: 12 months
Phase 1b- Safety and tolerability of IMGS-001 by frequency and severity of Adverse Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMGS-001 in people with Solid Tumor, run by ImmunoGenesis at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Schweizer, PhD (713-703-2952, charles.schweizer@immunogenesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a- Safety and tolerability of IMGS-001 by dose-limiting toxicities and adverse events (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.