The Phase 2 clincial trial (NCT05359861) is designed to evaluate the efficacy and safety of casdozokitug (formerly SRF388) in combination with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with atezolizumab plus bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC.

After a Lead-In Phase of up to 30 patients who will receive open-label casdozokitug + atezolizumab + bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a 1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).

For more information, please visit clinicaltrials.gov

The Phase 1/1b, open-label, first-in-human (FIH), dose-escalation and expansion clinical trial (NCT04374877) is designed to evaluate casdozokitug as a monotherapy and in combination in patients with solid tumors that will be conducted in 4 parts:

Part A: Casdozokitug monotherapy dose-escalation portion of the study evaluated the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of casdozokitug as monotherapy in patients with advanced solid tumors. A recommended Phase 2 dose of 10mg/kg was established.

Part B: Casdozokitug monotherapy expansion cohorts will evaluate the safety, efficacy, tolerability, PK, and pharmacodynamics of casdozokitug monotherapy in patients with advanced or metastatic ccRCC, advanced or metastatic HCC, and advanced or metastatic NSCLC in indication specific cohorts.

Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of casdozokitug in combination with pembrolizumab in patients with advanced RCC, HCC, or NSCLC. Based on preliminary results, Coherus initiated Part D.

Part D will evaluate the safety, preliminary efficacy, tolerability, and PK of casdozokitug in combination with toripalimab in patients with advanced NSCLC.

For more information, please visit clinictrials.gov

The Phase 1/2, open-label, first-in-human, dose-escalation and expansion clinical trial (NCT05635643) is designed to evaluate CHS-114 (SRF114) as a monotherapy in patients with advanced solid tumors and will be conducted in 2 parts:

Part A: CHS-114 monotherapy dose-escalation portion of the study will enroll approximately 30 patients with advanced solid tumors.

Part B: CHS-114 monotherapy expansion cohort(s) will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in indication specific cohort(s). Up to 40 patients will be enrolled.

For more information, please visit clinictrials.gov