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

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Study of SHR-1701 or Placebo in Combination With BP102 (Biosimilar to Bevacizumab) and XELOX in First-line Treatment of mCRC

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Colorectal Cancer (mCRC)
• Intervention / Treatment: Drug: SHR-1701、 BP102 、XELOX; Drug: SHR-1701、 BP102 、XELOX; Drug: placebo、 BP102、 XELOX

• Study Type: Interventional
• Enrollment (Anticipated): 439
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Qing Yang, M.D; Phone Number: +86 021-61053363; Email: yangqing@hrglobe.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with unresectable recurrent or metastatic adenocarcinoma of the colon or rectum confirmed histologically
2. 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
3. At least 1 measurable lesion according to RECIST V1.1
4. The vital organs are functioning well
5. ECOG score is 0 ~ 1
6. Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug

Exclusion Criteria:

1. Recurrent or metastatic lesions can be treated with radical surgery
2. Presence of central nervous system or meningeal metastases;
3. Moderate and severe ascites of clinical symptoms;Uncontrolled or moderate or greater pleural effusion or pericardial effusion
4. 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
5. 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
6. Subject with current interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy
7. Previous treatment with targeted T cell costimulatory molecules and immune checkpoint inhibitors;Previous treatment with antiepidermal growth factor receptor or any antiangiogenic drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SHR-1701 in combination with BP102 and XELOX（Phase 2）	Drug: SHR-1701、 BP102 、XELOX; 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; Drug: SHR-1701、 BP102 、XELOX; Phase 3：Randomized 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
EXPERIMENTAL: SHR-1701 in combination with BP102 and XELOX （Phase 3）	Drug: SHR-1701、 BP102 、XELOX; 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; Drug: SHR-1701、 BP102 、XELOX; Phase 3：Randomized 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
PLACEBO_COMPARATOR: placebo in combination with BP102 and XELOX	Drug: placebo、 BP102、 XELOX; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCR	Disease control rate，the proportion of patients with the best overall response of CR, PR, or stable disease (SD) 。	up to 2 years
OS	Overall survival ，from the date of first dose unitl the date of death from any cause。	up to 2 years
PFS	Progression-free survival from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed (assessed by independent radiological review committee (IRRC) based on iRECIST，by the investigators based on RECIST v1.1))。	up to 2 years
Duration of response	Duration of response，from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed	up to 2 years

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2021
• Primary Completion (ANTICIPATED): November 6, 2022
• Study Completion (ANTICIPATED): November 6, 2024

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (ACTUAL): April 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil
• Other Study ID Numbers: SHR-1701-III-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No