NCT05039944 is a Phase 2 clinical trial of SI-B001 in Colorectal Cancer, sponsored by Sichuan Baili Pharmaceutical Co., Ltd..

Who is sponsoring NCT05039944?

NCT05039944 is sponsored by Sichuan Baili Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05039944?

Interventions in NCT05039944: SI-B001, Irinotecan, FOLFIRI Protocol, FOLFOX Protocol.

What condition does NCT05039944 study?

NCT05039944 studies Colorectal Cancer.

Is NCT05039944 still recruiting?

NCT05039944 is currently terminated. Last updated 18 July 2024.

Last reviewed 2024-07-18 · How we verify

NCT05039944

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies

Terminated Phase 2 Last updated 18 July 2024

What this trial tests

Phase 2 trial testing SI-B001 in Colorectal Cancer in 7 participants. Terminated before completion.

Timeline

30 November 2021

Primary endpoint
6 June 2022

6 June 2022

Quick facts

Lead sponsor	Sichuan Baili Pharmaceutical Co., Ltd.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	30 November 2021
Primary completion	6 June 2022
Estimated completion	6 June 2022
Sites	1 location across China

Drugs / interventions tested

SI-B001 — full drug profile →
Irinotecan (irinotecan) — full drug profile →
FOLFIRI Protocol — full drug profile →
FOLFOX Protocol — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multi-center, open label Phase II clinical study is performed in patients with unresectable or metastatic malignant tumors of the digestive system (colorectal cancer, gastric cancer). This study is investigating the safety and efficacy of SI-B001 at monotherapy or optimal combination dose with chemotherapy in patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

HER3 in cancer: from the bench to the bedside.
Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2022 · cited 71× · PMID 36271429 · DOI 10.1186/s13046-022-02515-x
Colorectal cancer pathogenesis, oncogenic signaling networks and targeted therapeutic advances.
Chen Y, Zhang J, Ding Y, Zhu F, et al · · 2026 · PMID 41826571 · DOI 10.1186/s43556-026-00433-4
HER3 beyond the canonical paradigm: a versatile signaling hub in oncogenesis and therapeutic resistance.
Li Y, Wang Z, Gu M, Huang F, et al · · 2026 · PMID 41820966 · DOI 10.1186/s12967-026-07934-4

Verify or expand the search:

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other Sichuan Baili Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT04851444 — A Study of SI-F019 in Healthy Participants · Phase 1 · completed
NCT03853369 — Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection · unknown
NCT03855826 — Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection. · Phase 4 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05039944 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sichuan Baili Pharmaceutical Co., Ltd.
Last refreshed: 18 July 2024

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/NCT05039944.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing