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NCT06014502
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
Phase 1 trial testing IMGS-001 in Solid Tumor in 105 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | ImmunoGenesis |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 7 September 2023 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2027 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- IMGS-001 — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
ImmunoGenesis — full company profile →
Who can join
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06014502
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06014502 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ImmunoGenesis
- Last refreshed: 6 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06014502.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing