Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Trifluridine

Immunoglobulins

Antimetabolites

Antiviral Agents

Sym004 will be administered as a loading dose of 9 mg/kg on Cycle 1 Day 1, followed by weekly doses of 6 mg/kg beginning Cycle 1 Day 8.

TAS-102 is commercially available and will be administered as per local prescribing instructions.

Sym004 is a 1:1 mixture of two recombinant mAbs (futuximab and modotuximab) which bind specifically to non-overlapping epitopes located in the extracellular domain (ECD) of the EGFR.

Sym004

TAS-102 is a combination of trifluridine, a thymidine-based nucleic acid analogue, and tipiracil, a thymidine phosphorylase inhibitor.

TAS-102

Josep Tabernero, MD, PhD

This is a Phase 3, randomized, open-label, 2-arm trial designed to evaluate overall survival (OS) following treatment with Sym004, an investigational medicinal product (IMP), versus TAS-102 (trifluridine/tipiracil), a comparator (control) agent.

Randomization is in the ratio of 1:1 to either Sym004 (Arm A) or TAS-102 (Arm B) in genomically-selected patients with chemotherapy-refractory or relapsed metastatic colorectal carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) therapy.

Following consent, centralized genomic analysis will be conducted on blood samples obtained from each potential patient. Double-negative (DN) results as defined in trial inclusion criteria will be required for initial eligibility prior to randomization. Patients with DNmCRC will continue in the screening process. Once deemed fully eligible, patients will be randomized to either Arm A or Arm B (collectively referred to as protocol therapy).

Dosing cycles of 28 days with the assigned protocol therapy will continue until a protocol-specified discontinuation criterion is met. Following treatment discontinuation, patients will continue to be followed for OS.

Sym004 Versus TAS-102 in Patients With mCRC

A Phase 3, Randomized, Open-Label, Multicenter Trial of Sym004 Versus Trifluridine/Tipiracil (TAS-102) in Patients With Chemotherapy-Refractory or Relapsed Metastatic Colorectal Carcinoma and Acquired Resistance to Anti-EGFR Monoclonal Antibody Therapy

Time (in months) from the date of randomization to the date of death. In the absence of death confirmation or for patients alive as of the OS data cut-off date (i.e., date upon reaching 445 deaths), OS will be censored at the date of last study follow-up, or the cut-off date, whichever is earlier.

Time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause.

Investigator-assessed radiological disease progression (per RECIST v1.1) with the following key censoring rules:

* Patients who are alive with no disease progression as of the analysis cut-off date will be censored at the date of the last tumor assessment.
* Patients who receive non-study cancer treatment before disease progression will be censored at the date of the last evaluable tumor assessment before the initiation of non-study cancer treatment.
* Patients with clinical, but not radiologic, evidence of progression will be censored at the date of the last evaluable tumor assessment before the clinical progression assessment.

Defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR). Assessed approximately every 8 weeks (at the end of even-numbered cycles).

Defined as the proportion of patients with objective evidence of CR, PR, or stable disease (SD). Assessed approximately every 8 weeks (at the end of even-numbered cycles).

Time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, with the same censoring rules as for PFS.

AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology and the severity of the toxicities will be graded according to the Common Terminology Criteria for Adverse Events (Version 5) (CTCAE v5), where applicable, from signing of informed consent up to 30 days after the final dose of Sym004.

Serum sampling to assess the potential for ADA formation are planned on the following visits: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Day 1 of odd numbered cycles thereafter, the End of Treatment Visit, and the 1-Month Follow-up Visit.

Cmin is defined as the serum concentration at the start of infusion. The serum concentration of Sym004 is the sum of the two constituting mAbs, futuximab and modotuximab. Sparse sampling at 7 timepoints are planned on the following visits: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1, End of Treatment Visit.

Cmax is defined as the serum concentration at the end of infusion. The serum concentration of Sym004 is the sum of the two constituting mAbs, futuximab and modotuximab. Sparse sampling at 7 timepoints are planned on the following visits: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1, End of Treatment Visit.

Symphogen A/S

Skin and Connective Tissue Diseases

Breast Neoplasms

35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Drew Rasco, MD

The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.

This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD as a TAS-102 component compared with FTD alone in patients with advanced solid tumors (excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the extension phase.

Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone

Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.

Taiho Oncology, Inc.

Immunomodulating Agents

Participants will receive botensilimab at dose 1 given IV and balstilimab given IV.

Participants will receive botensilimab at dose 2 given IV and balstilimab given IV.

Participants will receive botensilimab dose 1 given IV.

Participants will receive botensilimab dose 2 given IV.

Participants will receive select standard of care as determined by the investigator.

An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.

Botensilimab

An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody.

Balstilimab

Regorafenib or trifluridine and tipiracil.

Standard of Care

Medical Director

This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.

This study will enroll adult participants with a confirmed diagnosis of unresectable metastatic colorectal adenocarcinoma (CRC) who have had prior chemotherapy for metastatic or recurrent CRC.

This study will consist of 5 cohorts. In the first and second cohorts, participants will receive 1 of 2 different doses of botensilimab intravenously (IV) and balstilimab IV. In the third and fourth cohorts, participants will receive 1 of 2 different doses of botensilimab. In the fifth cohort, participants will receive standard of care consisting of the investigator's choice of regorafenib or trifluridine and tipiracil.

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

A Randomized, Open-Label, Phase 2 Study of Botensilimab (AGEN1181) as Monotherapy and in Combination With Balstilimab (AGEN2034) or Investigator's Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer

Objective response rate is defined as the proportion of participants with complete response or partial response, as assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Duration of response is defined as the time from initial objective radiographic response until disease progression or death, whichever occurs first, as assessed using RECIST 1.1.

Progression-free survival is defined as the time from randomization until disease progression or death, whichever occurs first, as assessed using RECIST 1.1.

Overall survival is defined as the time from randomization until death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sym004 Versus TAS-102 in Patients With mCRC	NCT03717038	Metastatic Colo... Colorectal Canc... Carcinoma	Sym004 TAS-102	18 Years -	Symphogen A/S
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone	NCT01867866	Advanced Solid ...	TAS-102 Trifluridine	18 Years -	Taiho Oncology, Inc.
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone	NCT01867866	Advanced Solid ...	TAS-102 Trifluridine	18 Years -	Taiho Oncology, Inc.
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer	NCT05608044	Metastatic Colo...	Botensilimab Balstilimab Standard of Car...	18 Years -	Agenus Inc.
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer	NCT05608044	Metastatic Colo...	Botensilimab Balstilimab Standard of Car...	18 Years -	Agenus Inc.

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