A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC

NCT04856787 | Terminated Phase 2

• 1 other identifier: SHR-1701-III-301
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC.

Conditions

Metastatic Colorectal Cancer (mCRC)

Outcome Measures

Primary Outcomes (3)

• Phase 2:ORR

  Objective response rate (assessed by the investigators based on RECIST v1.1)

  up to 2 years

• Phase 2:Incidence of Adverse Events (AEs) by CTCAE v5.0

  Assess safety and tolerability of SHR-1701 in combination with BP102 and XELOX

  up to 2 years

• Phase 3:PFS

  Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)

  from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

Secondary Outcomes (4)

• DCR

  up to 2 years

• OS

  up to 2 years

• PFS

  up to 2 years

• Duration of response

  up to 2 years

Study Arms (3)

SHR-1701 in combination with BP102 and XELOX（Phase 2）

EXPERIMENTAL

Drug: SHR-1701、 BP102 、XELOX

SHR-1701 in combination with BP102 and XELOX （Phase 3）

EXPERIMENTAL

Drug: SHR-1701、 BP102 、XELOX

placebo in combination with BP102 and XELOX

PLACEBO COMPARATOR

Drug: placebo、 BP102、 XELOX

Interventions

SHR-1701、 BP102 、XELOX DRUG

Phase 2：Single Group Drug:SHR-1701 30mg/kg，IV ,every 3 week Drug：BP102 7.5mg/kg，IV,every 3 week Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

SHR-1701 in combination with BP102 and XELOX（Phase 2）

placebo、 BP102、 XELOX DRUG

Phase 3：Randomized Drug:Placebo 30mg/kg，IV ,every 3 week Drug：BP102 7.5mg/kg，IV,every 3 week Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

placebo in combination with BP102 and XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unresectable recurrent or metastatic adenocarcinoma of the colon or rectum confirmed histologically
• For subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
• At least 1 measurable lesion according to RECIST V1.1
• The vital organs are functioning well
• ECOG score is 0 \~ 1
• Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug

You may not qualify if:

• Recurrent or metastatic lesions can be treated with radical surgery
• Presence of central nervous system or meningeal metastases;
• Moderate and severe ascites of clinical symptoms;Uncontrolled or moderate or greater pleural effusion or pericardial effusion
• Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in the case of regular antihypertensive therapy) and prior hypertensive crisis or hypertensive encephalopathy
• Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlledSubjects with a history of myocardial infarction or unstable angina pectoris
• Subject with current interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy
• Previous treatment with targeted T cell costimulatory molecules and immune checkpoint inhibitors;Previous treatment with antiepidermal growth factor receptor or any antiangiogenic drug

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Qiu MZ, Bai Y, Wang J, Gu K, Yang M, He Y, Yi C, Jin Y, Liu B, Wang F, Chen YK, Dai W, Jiang Y, Huang C, Xu RH, Luo HY. Addition of SHR-1701 to first-line capecitabine and oxaliplatin (XELOX) plus bevacizumab for unresectable metastatic colorectal cancer. Signal Transduct Target Ther. 2024 Dec 16;9(1):349. doi: 10.1038/s41392-024-02063-0.

  PMID: 39676137 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: June 22, 2021
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CN (1)