A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer

NCT07750041 | Not Yet Recruiting Phase 1

• 1 other identifier: SYS6090-008
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This study constitutes an open-label, multi-cohort, multi-center Phase Ib/II clinical study, developed to assess the safety, tolerability, and therapeutic efficacy of SYS6090 injection when administered in combination with bevacizumab, or in triple combination with bevacizumab and chemotherapy, among patients diagnosed with advanced colorectal cancer.

Conditions

Unresectable Advanced or Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Recommended Phase 2 Dose (RP2D), Safety and Tolerability

  RP2D of SYS6090 combination therapy,Safety and tolerability are evaluated via incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up.

  up to approximately 3 years after the first enrollment

• Objective Response Rate (ORR) assessed per RECIST v1.1

  ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with at least one visit confirmed complete response (CR) or partial response (PR), for all cohorts in Phase Ib and Cohort 1 of Phase II expansion stage.

  up to approximately 3 years after the first enrollment

• Progression-Free Survival (PFS) assessed per RECIST v1.1

  PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the time from the date of randomization or first study treatment until the date of confirmed progressive disease (PD), or death by any cause in the absence of progression, regardless of whether the participant withdrew from study therapy or received another anticancer therapy prior to progression, for Cohort 2 of Phase II expansion stage.

  up to approximately 3 years after the first enrollment

Study Arms (7)

Ib-Randomized Arm 1

EXPERIMENTAL

Enrolled Subjects will be randomized to receive SYS6090 at the fixed dose level A in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only.

Drug: SYS6090 (Fixed Dose Level A) + bevacizumab

Ib-Randomized Arm 2

EXPERIMENTAL

Enrolled Subjects will be randomized to receive SYS6090 at the fixed dose level B in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only.

Drug: SYS6090 (Fixed Dose Level B ) + bevacizumab

II-Cohort 1- Randomized Arm A

EXPERIMENTAL

Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and mFOLFOX6

Drug: SYS6090 RP2D + bevacizumab +mFOLFOX6

II-Cohort 1- Randomized Arm B

EXPERIMENTAL

Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab

Drug: SYS6090 RP2D + bevacizumab

II-Cohort 1- Randomized Arm C

EXPERIMENTAL

Enrolled Subjects will be randomized to receive regorafenib

Drug: Regorafenib

II-Cohort 2- Randomized Arm D

EXPERIMENTAL

Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and FOLFOXIRI

Drug: SYS6090 PR2D+ bevacizumab + FOLFOXIRI

II-Cohort 2- Randomized Arm E

ACTIVE COMPARATOR

Enrolled Subjects will be randomized to receive bevacizumab combined with FOLFOXIRI

Drug: bevacizumab + FOLFOXIRI

Interventions

SYS6090 (Fixed Dose Level A) + bevacizumab DRUG

Participants will receive intravenous SYS6090 at fixed dose level A combined with intravenous bevacizumab, administered per cycle schedule specified in study protocol, for advanced/palliative unresectable pMMR/MSS colorectal cancer.

Ib-Randomized Arm 1

SYS6090 (Fixed Dose Level B ) + bevacizumab DRUG

Participants will receive intravenous SYS6090 at fixed dose level B plus intravenous bevacizumab per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.

Ib-Randomized Arm 2

SYS6090 RP2D + bevacizumab +mFOLFOX6 DRUG

Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab combined with standard mFOLFOX6 chemotherapy regimen (oxaliplatin, leucovorin, fluorouracil), administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.

II-Cohort 1- Randomized Arm A

SYS6090 RP2D + bevacizumab DRUG

Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab, administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.

II-Cohort 1- Randomized Arm B

Regorafenib DRUG

Oral regorafenib monotherapy as standard control for metastatic pMMR/MSS colorectal cancer.

II-Cohort 1- Randomized Arm C

SYS6090 PR2D+ bevacizumab + FOLFOXIRI DRUG

Participants will receive intravenous SYS6090at RP2D plus intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.

II-Cohort 2- Randomized Arm D

bevacizumab + FOLFOXIRI DRUG

Participants will receive intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.

II-Cohort 2- Randomized Arm E

Eligibility Criteria

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

You may qualify if:

• Subjects must be ≥18 years of age.
• Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer with pMMR/MSS status, assigned to corresponding cohorts as follows:
• Cohort 1 (2L/3L) of Phase Ib \& Phase II: Subjects must have disease progression after no more than 2 lines of standard systemic therapy (prior regimens must contain fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy); tumor tissue confirmed as pMMR by IHC or MSS by NGS/PCR; Cohort 2 (1L) of Phase Ib \& Phase II: Subjects have received no prior systemic anti-tumor therapy for advanced disease; tumor tissue confirmed as pMMR by IHC or MSS by NGS/PCR.
• At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Expected survival ≥ 3 months.
• Has protocol-defined adequate organ and bone marrow function.

You may not qualify if:

• Subjects with clinically active central nervous system metastases;
• with a history of other primary malignant tumors within 5 years before administration;
• Subjects assigned to Cohort 1 who have received prior regorafenib treatment.;
• Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening;
• Uncontrolled or significant cardiovascular disease;
• Clinically uncontrolled pleural effusion, ascites or pericardial effusion;
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline .

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Study Sites (1)

Fujian Cancer Hospital

Fujian, Fuzhou, 350014, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; regorafenib

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

0311-69085587; ctr-contact@cspc.cn

LIN

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 30, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (1)