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Advanced Solid MalignanciesPhase 1/2NCT06028074

Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

A Phase 1/2 study testing GIM122 in people with Advanced Solid Malignancies, run by Georgiamune Inc at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Malignancies
What is being tested?
GIM122
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
11 sitesUnited States
Study dates
12 Dec 2023to Dec 2026
Phase
Phase 1/2
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

  • General
  • Written informed consent
  • ECOG performance status 0-1.
  • Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
  • Recommended Double methods of contraception 90-days post treatment Cancer Specific
  • Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
Show all 10Show fewer
  • Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
  • Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
  • No other lines of therapy that are available

Who cannot join

  • General
  • Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
  • Women who are pregnant or breastfeeding
  • History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
  • Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
  • Current second malignancy at other sites
Show all 21Show fewer
  • Leptomeningeal disease
  • Spinal cord compression
  • Symptomatic or new or enlarging central nervous system (CNS) metastases
  • Treatment-specific Exclusion Criteria
  • Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
  • Has undergone a major surgery < 1 month prior to administration of GIM-122
  • Has received radiation therapy within 2 weeks prior to administration of GIM-122
  • Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
  • Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
  • Prior treatment with other immune modulating agents within < 4 weeks prior to the first dose of GIM-122.
  • Has a diagnosis of immunodeficiency, either primary or acquired
  • Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
  • Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
  • Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
  • Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date > 30 days prior to administration of GIM-122).

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

LumaBridge CRO contact

210-563-8441

contact@lumabridge.com

11 sites in 1 country

United States11 sites, 11 recruiting

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texas, 75246

    Charles Cowey, MD, 214-370-1000

    Stephanie Cannon, 972-490-2939

    Recruiting

  • NEXT Oncology Dallas

    Irving, Texas, 75039

    Alexis Praytor, 972-893-8800

    Shiraj Sen, MD, PhD

    Recruiting

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

    310-294-0438

    Omid Hamid, MD, PhD

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Thomas Won, thomas.won@med.usc.edu

    Gino In, MD

    Recruiting

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

    Thu Ly, 310-794-3883, tply@mednet.ucla.edu

    Bartosz Chmielowski, MD, PhD

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

    Juanita Dwingelo, MS, PhD, ACRP-CP, 502-629-3681, juanita.vondwingelo@nortonhealthcare.org

    Jaspreet Grewal, MD, PhD

    Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

    Amber Hilyard, ahilyard@tnonc.com

    Jeffery S Russell, MD, PhD

    Recruiting

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jersey, 08903

    Taryn Bollaro, 732-853-3229, tb509@cinj.rutgers.edu

    Sanjay Goel, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Faith McFadden, 804-628-0616, mcfaddenfr@vcu.edu

    Jonathan Berkman, MD

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

    Markee Micu, 415-319-3400, markee.micu@ucsf.edu

    Katy Tsai, MD

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Kandyce Treijo, 941-377-9993

    Manish Rajni Patel, MD

    Recruiting

Other trials in United States

About this study

Official title: A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation With Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects With Advanced Solid Malignancies

GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.

Read the detailed description

This is a Phase 1/2, open label, first-in-human (FIH), multicenter, dose escalation study with enrichments and dose expansion cohorts at RP2D, designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of GIM-122 administered as a single agent in adults with advanced solid malignancies. This study will be conducted in 2 parts: Phase 1 or Part A (dose escalation and enrichment) and Phase 2 or Part B (dose optimization and cohort expansion).

Being tested
GIM122
Keywords
solid tumor, advanced malignancies, GIM-122

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIM122Drug

    Also called GIM-122

    GIM-122 administered IV once every 3 weeks or every 2 weeks

Study groups in NCT06028074
Study groupRoleWhat they receive
Intravenous administration of GIM-122ExperimentalGIM-122
Receives: Drug: GIM122

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities [DLT] with GIM-122

    To identify dose limiting toxicities [DLT] with GIM-122

    Measured: 18 months

  2. Maximum tolerated dose [MTD] of GIM-122

    To identify maximum tolerated dose [MTD] of GIM-122

    Measured: 18 months

  3. Recommended Phase 2 Dose [RP2D] of GIM-122

    To identify Recommended Phase 2 Dose [RP2D] of GIM-122

    Measured: 18 Months

  4. Overall response rate (ORR) -Part B of the study

    To identify overall response rate (ORR) in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy

    Measured: 36 months

  5. Anti-tumor activity of GIM-122

    To assess anti-tumor activity of GIM-122 as a single agent in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy

    Measured: 36 months

  6. Incidence and severity of AE / SAEs and tolerability

    To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading

    Measured: 36 months

Secondary outcomes (10)

  1. Area under the plasma concentration versus time curve (AUC)

    To preliminarily evaluate the AUC in patients with advanced malignant tumors

    Measured: 36 months

  2. Peak Plasma Concentration (Cmax)

    To preliminarily evaluate Cmax in patients with advanced malignant tumors

    Measured: 36 months

  3. Time of peak plasma concentration (Tmax)

    To preliminarily evaluate Tmax in patients with advanced malignant tumors

    Measured: 36 months

  4. Overall Response Rate (ORR) - Part A of the study

    To preliminarily evaluate ORR in patients with advanced malignant tumors

    Measured: 36 months

  5. Duration of response (DOR)

    To preliminarily evaluate DOR in patients with advanced malignant tumors

    Measured: 36 months

  6. Disease control rate (DCR)

    To preliminarily evaluate DCR in patients with advanced malignant tumors

    Measured: 36 months

  7. Best overall response (BOR)

    To preliminarily evaluate BOR in patients with advanced malignant tumors

    Measured: 36 months

  8. Progression-free survival (PFS)

    To preliminarily evaluate PFS in patients with advanced malignant tumors

    Measured: 36 months

  9. Overall survival (OS) rates at 12 months

    To preliminarily evaluate OS in patients with advanced malignant tumors at 12 Months

    Measured: 36 months

  10. Tumor expression of immunological markers

    To analyze tumor expression of immunological markers

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start12 Dec 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Part A: Dose Escalation and Enrichment, Part B: Dose Expansion in specified tumor types
Masking
None (open label)
Enrolment
111 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028074
Sponsor's protocol ID
GIM122-CT01
Status last verified
Aug 2026
First submitted
31 Aug 2023
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GIM122 in people with Advanced Solid Malignancies, run by Georgiamune Inc at 11 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 10 inclusion and 21 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 LumaBridge CRO (210-563-8441, contact@lumabridge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities [DLT] with GIM-122 (time frame: 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028074.

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 17 Aug 2026.

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