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A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

ConditionRefractory Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.

About this trial

The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants.

The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Confirmed by histological and/or cytological examination as unresectable metastatic colon or rectal adenocarcinoma;

2. At least one measurable tumor lesion (RECIST v1.1);

3. Previously received fluorouracil, oxaliplatin, and irinotecan based chemotherapy; had previously undergone or was unsuitable for anti-VEGF therapy. (For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy.);

4. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;

Disqualifiers

1. Having a second active primary malignancy within the past 5 years;

2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (e.g., radiotherapy or surgery) or corticosteroid treatment within 2 weeks prior to the first administration of the study treatment;

3. Any active infection requiring systemic treatment within 2 weeks prior to the initiation of the study treatment;

4. Pleural effusion, pericardial effusion, or ascites that is uncontrolled or has required drainage or medical intervention within 4 weeks prior to the first administration of the study treatment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suvemcitug injection, trifluridine/tipiracil tablets

    Drug

    Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²

  • Suvemcitug placebo injection, trifluridine/tipiracil tablets

    Drug

    Suvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m².

Treatment groups

464 Participants
are divided into 2 treatment groups
Group A: Suvemcitug+ trifluridine/tipiracil tabletsExperimental treatment 1 intervention
Group B: Placebo+ trifluridine/tipiracil tabletsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phase Ib: dose limiting toxicity (DLT)

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

Phase Ib: Adverse Events

The incidence (number of participants) and severity of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE v5.0

Time frame
From signing informed consent form until 28 days after the last dose of study treatment, up to about 18 months
3

Phase Ib: Tolerance

Number of participants who experienced adverse event related dose interruption, dose reduction and treatment discontinuation as assessed by investigators.

Time frame
From signing informed consent until 28 days after the last dose of study treatment, for up to 18 months
4

Phase III: overall survival (OS)

OS is the time interval from the date of randomization to death from any cause.

Time frame
For about 18 months from the randomization of the last participant

Secondary outcomes

1

Suvemcitug Serum concentration change over time of all participants

Area under the serum concentration versus time curve (AUC)

Time frame
For about 6 cycles, each cycle is 28 days.
2

Peak Suvemcitug serum concentration (Cmax) of all participants

Time frame
For about 6 cycles, each cycle is 28 days
3

The time taken to reach peak Suvemcitug concentration after administration (Tmax)

Time frame
For about 6 cycles, each cycle is 28 days
4

The time required for Suvemcitug concentration in the serum to decrease by half (t1/2)

Time frame
For about 6 cycles, each cycle is 28 days

Other outcomes

Sponsors and contacts

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

Jiangsu Simcere Pharmaceutical Co., Ltd.

Lead sponsor

Jiangsu Simcere Biologics Co., Ltd

Collaborator

Source ClinicalTrials.gov
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