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NCT07281716
Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC
Phase 1, PHASE2 trial testing Nadunolimab in Metastatic Microsatellite Stable Colorectal Carcinoma in 24 participants. Currently enrolling.
15 December 2028
Quick facts
| Lead sponsor | Dan Feng |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 December 2025 |
| Primary completion | 15 December 2028 |
| Estimated completion | 15 December 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Nadunolimab — full drug profile →
- Toripalimab (TORIPALIMAB) — full drug profile →
Conditions studied
- Metastatic Microsatellite Stable Colorectal Carcinoma — all drugs for Metastatic Microsatellite Stable Colorectal Carcinoma →
Sponsor
Dan Feng
Who can join
18 and older, any sex, with Metastatic Microsatellite Stable Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting toxicity (DLT), while Phase 2 will evaluate objective response rate (ORR), including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Exploratory analyses will investigate immunomodulatory effects through tumor and peripheral blood studies, and treatment will continue every 3 weeks for up to 1 year or until disease progression.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07281716
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nadunolimab
Trials testing the same drug.
- NCT07284485 — Immunoprevention for High-risk Lung Lesions · Phase 2 · recruiting
- NCT06548230 — A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodyspl · Phase 1, PHASE2 · recruiting
Other recruiting trials for Metastatic Microsatellite Stable Colorectal Carcinoma
Currently open trials in the same condition.
- NCT06654037 — Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metas · Phase 1 · recruiting
- NCT05691491 — Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness · Phase 1, PHASE2 · recruiting
- NCT05672316 — Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal · Phase 1, PHASE2 · active not recruiting
- NCT05627635 — FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite · Phase 1, PHASE2 · active not recruiting
- NCT03983993 — Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer · Phase 2 · active not recruiting
Other Dan Feng trials
Trials by the same sponsor.
- NCT07277322 — Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases · Phase 1, PHASE2 · not yet 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 NCT07281716 (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 Dan Feng
- Last refreshed: 19 February 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/NCT07281716.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing