The randomized Phase 2 clinical trial (NCT06679985) is designed to evaluate the efficacy and safety of two clinically active doses of casdozokitug in combination with toripalimab plus bevacizumab compared to toripalimab plus bevacizumab in 72 patients with first-line unresectable, locally advanced or metastatic HCC.

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 clinicaltrials.gov.

The Phase 1/1b, open-label, first-in-human, dose-escalation and expansion clinical trial (NCT05635643) is designed to evaluate CHS-114 as a monotherapy in patients with advanced solid tumors and will be conducted in 3 parts:

Arm 1a: CHS-114 monotherapy dose-escalation portion of the study will enroll approximately 30 patients with advanced solid tumors.

Arm1b: CHS-114 monotherapy expansion cohort(s) will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in indication specific cohort(s).

Arm 2: CHS-114 +toripalimab combination dose-escalation portion of the study will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in combination with toripalimab in indication specific cohort(s). Up to approximately 6-12 participants will be enrolled.

Arm 3: CHS-114 + toripalimab combination dose-expansion portion of the study will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in combination with toripalimab in patients with second-line head and neck squamous cell carcinoma. Up to approximately 40 participants will be randomized to two dosing arms.

For more information, please visit clinicaltrials.gov.

The Phase 1b, open-label, first-in-human clinical trial (NCT06657144) is designed to evaluate CHS-114 in combination with toripalimab in patients with advanced solid tumors:

Cohort A: CHS-114 + toripalimab combination dose study will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in combination with toripalimab in patients with second-line unresectable, locally advanced or metastatic gastric, Gastro-esophageal-junction (GEJ), or esophageal adenocarcinoma that is human epidermal growth factor receptor 2 (HER2) – negative and microsatellite stable (MSS)/proficient mismatch repair (pMMR). Up to approximately 40 participants will be randomized to two dosing arms.

For more information, please visit clinicaltrials.gov.