Health TrialsbyHealthPanel

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

ConditionUnresectable Advanced or Metastatic Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must be ≥18 years of age.

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

  • Regorafenib

    Drug

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

  • 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.

  • 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.

Treatment groups

260 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Ib-Randomized Arm 1Experimental treatment 1 intervention
Group B: Ib-Randomized Arm 2Experimental treatment 1 intervention
Group C: II-Cohort 1- Randomized Arm AExperimental treatment 1 intervention
Group D: II-Cohort 1- Randomized Arm BExperimental treatment 1 intervention
Group E: II-Cohort 1- Randomized Arm CExperimental treatment 1 intervention
Group F: II-Cohort 2- Randomized Arm DExperimental treatment 1 intervention
Group G: II-Cohort 2- Randomized Arm EActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to approximately 3 years after the first enrollment
2

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.

Time frame
up to approximately 3 years after the first enrollment
3

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.

Time frame
up to approximately 3 years after the first enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: