Trial reportInternational journal of colorectal disease2025
The efficacy and safety of suvemcitug, envafolimab, and FOLFIRI in microsatellite-stable or mismatch repair-proficient colorectal cancer: preliminary results of a phase 2 study.
Trial report in International journal of colorectal disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05148195 (An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors
Who cites it
2 citing papers in PubMed.
- TACE plus lenvatinib and envafolimab for conversion therapy in unresectable HCC: a prospective pilot study.Frontiers in immunology · 2026Trial
- Envafolimab - novel anti-PD-1/PD-L1 antibody in cancer treatment.Frontiers in immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis phase II study is designed to evaluate the combination therapy involving suvemcitug and envafolimab with FOLFIRI in microsatellite-stable or mismatch repair-proficient (MSS/pMMR) colorectal cancer (CRC) in the second-line treatment setting.
methodsThis study is a non-randomized, open-label prospective study comprising multiple cohorts (NCT05148195). Here, we only report the data from the CRC cohort. Participants received envafolimab, suvemcitug, and FOLFIRI until disease progression, unacceptable toxicity, or voluntary withdrawal. The recommended dose (RD) and objective response rate (ORR) by investigator assessment were primary endpoints. Secondary endpoints comprised progression-free survival (PFS) and duration of response (DoR). Disease control rate (DCR), overall survival (OS), and safety were also analyzed.
resultsAt the data cutoff, no dose-limiting toxicity event was observed in the safety run-in stage, and 2 mg/kg Q2W was declared as RD for suvemcitug combined with envafolimab and FORFIRI. Among 20 patients, 50.0% and 10.0% had been treated with prior antiangiogenic agents and anti-EGFR agents, respectively. ORR and DCR were 25.0% (95% CI 8.7-49.1%) and 90.0% (95% CI 68.3-98.8%), and DoR was 4.1 months (95% CI 3.02, NE). The median PFS and median OS were 5.6 months (95% CI 4.0-8.3) and not reached (95% CI 8.5, NE) by the time of study closure. Neutrophil count decreased, white blood cell count decreased, and hypertension were the most common grade ≥3 treatment-related adverse events (TRAE).
conclusionsThe safety profile was manageable and the preliminary anti-tumor efficacy was observed in patients with MSS/pMMR CRC in this study, who had failed prior to one line of therapy.
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