A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors

Phase
Recruitment status
Participants
Lead sponsor
Coherus Oncology, Inc.
Start date
Number of sites

Summary
The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.
Short title
A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
Official title
A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors (TREGCHECK 102)

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
Coherus Oncology, Inc.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Timeframe: From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years)

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment

    Timeframe: Up to approximately 2.25 years

    ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.

  2. Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment

    Timeframe: Up to approximately 2.25 years

    DOR is defined as the time from first documentation of response (CR or PR) to first radiographic documentation of progressive disease or death due to any cause according to RECIST v1.1.

  3. Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment

    Timeframe: Up to approximately 2.25 years

    DCR is defined as the percentage of participants who achieve a confirmed CR or PR or stable disease (SD) lasting ≥ 12 weeks according to RECIST v1.1.

  4. Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment

    Timeframe: Up to approximately 2.25 years

    PFS is defined as the time of the first dose of study treatment to the time of the first documented unequivocal disease progression assessed per RECIST v1.1 or death due to any cause (whichever occurs first).

  5. Landmark PFS Rates

    Timeframe: Months 6, 9, and 12

  6. Maximum Observed Serum Concentration (Cmax) of CHS-114

    Timeframe: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  7. Time to Reach Cmax (Tmax) of CHS-114

    Timeframe: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  8. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CHS-114

    Timeframe: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  9. Number of Participants With Anti-drug Antibodies (ADAs)

    Timeframe: Up to approximately 2.25 years

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
  • Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs) not constituting a safety risk per Investigator judgement.

Cohort A (2L Gastric, Gastro-esophageal-junction [GEJ], Esophageal Adenocarcinoma [EAC]) Specific Inclusion Criteria:

  • Histologically or cytologically documented unresectable, locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma that is human epidermal growth factor receptor 2 (HER2) - negative and microsatellite stable (MSS)/proficient mismatch repair (pMMR).
  • Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting).
  • Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment.

Cohort B (2L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Inclusion Criteria:

  • Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
  • Progressed during or after first line systemic therapy including a doublet of platinum and fluoropyrimidine or paclitaxel with or without anti-PD-1/PD-L1-directed therapy or anti-CTLA-4 and anti-PD-1/PD-L1-directed combination therapy.
  • Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
  • Consent to provide archival tumor tissue sample (baseline) is required for enrolment.

Cohort C (1L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Inclusion Criteria:

  • Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
  • Consent to provide baseline tumor tissue is required.
  • Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
  • Calculated creatinine clearance ≥60 mL/min.

Cohort D, Arms D1 and D2 (4L+ Colorectal Carcinoma [CRC]) - Specific Inclusion Criteria:

  • Histologically and/or cytologically documented unresectable advanced or metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability/mismatch repair status for each participant must be documented, according to country level guidelines.
  • Participants who have no available therapies with a proven clinical benefit available in the participant's country per investigator. These therapies include the following: fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, anti-VEGF biological therapy (eg, bevacizumab, aflibercept, ramucirumab), an anti-EGFR therapy (eg, cetuximab, panitumumab) if RAS wildtype unless right-sided, either trifluridine/tipiracil, fruqintinib or regorafenib, and a BRAF inhibitor (ie, encorafenib) in BRAF V600E mutant).
  • Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxalipatin-based therapy in the metastatic setting.
  • Consent to provide baseline tumor tissue sample is required for enrolment.

Key Exclusion Criteria:

  • History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.
  • Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids.
  • Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study.
  • Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
  • History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.
  • Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results.

Cohort A (2L Gastric, Gastro-esophageal-junction [GEJ], Esophageal Adenocarcinoma [EAC]) Specific Exclusion Criteria:

  • Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
  • Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).

Cohort B (2L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Exclusion Criteria:

  • Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
  • Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).

Cohort C (1L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Exclusion Criteria:

  • Received ≥ 1 prior systemic anticancer therapies for advanced or metastatic disease.
  • Participants who progressed during or within 6 months following the last dose of neoadjuvant, or perioperative therapy with curative intent.
  • Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).
  • Known dihydropyrimidine dehydrogenase deficiency or thymidine synthase gene polymorphism predisposing the participant to 5-FU toxicity.
  • Known allergies to 5-FU or cisplatin.

Note: Other protocol-specified inclusion/exclusion criteria apply.

Sources for eligibility

  • The University of Arizona Cancer CenterTucson, United StatesWithdrawn
  • City of HopeDuarte, United StatesRecruiting
  • University of Colorado - Aurora Cancer CenterAurora, United StatesRecruiting
  • Winship Cancer Center - Emory UniversityAtlanta, United StatesRecruiting
  • Ochsner HealthNew Orleans, United StatesRecruiting
  • Henry Ford Health SystemDetroit, United StatesRecruiting
  • Comprehensive Cancer Center of NevadaLas Vegas, United StatesRecruiting
  • Christus St Vincent Regional Medical CenterSanta Fe, United StatesRecruiting
  • START New YorkLake Success, United StatesRecruiting
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting
  • University of Pittsburg Medical Center _UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting
  • Prisma Health Cancer InstituteGreenville, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • Texas Oncology - Central SouthAustin, United StatesRecruiting
  • START San Antonio, LLC.San Antonio, United StatesRecruiting
  • Huntsman Cancer Institute, University of UtahSalt Lake City, United StatesRecruiting
  • START Mountain Region, LLC.West Valley City, United StatesRecruiting
  • Virginia Cancer SpecialistsFairfax, United StatesRecruiting
  • Virginia Oncology AssociatesNorfolk, United StatesWithdrawn
  • Changhua Christian HospitalChang-hua, TaiwanRecruiting
  • E-Da Cancer HospitalKaohsiung City, TaiwanRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanRecruiting
  • Taichung Veterans General HospitalTaichung, TaiwanRecruiting
  • China Medical University HospitalTaichung, TaiwanRecruiting

And 5 more, listed on the interactive page.

Sources for sites

Sources for references

Related records

Drugs (4)

Lead sponsors (1)

Conditions (4)

Targets (2)