1. A Randomized Phase 3 Study of MRTX949 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation
Primary Objective:
- Compare the effectiveness of MRTX949 and docetaxel in improving overall survival (OS).
Secondary Objectives:
- Evaluate progression-free survival (PFS) using RECIST v1.1.
- Assess objective response rate (ORR) and disease control rate (DCR).
- Measure the duration of response (DoR).
- Evaluate safety and tolerability.
- Analyze patient-reported outcomes (PROs) on quality of life (QoL).
2. An Open-label Phase 1b Study of ORIC-101 in Combination with Anticancer Therapy in Patients with Advanced or Metastatic Solid Tumors
Primary Objectives:
- Assess the safety and tolerability of ORIC-101 in combination with anticancer therapy.
- Determine the recommended Phase 2 dose (RP2D).
Secondary Objectives:
- Evaluate preliminary antitumor activity (ORR, PFS, OS).
- Study the pharmacokinetics (PK) of ORIC-101.
Exploratory Objectives:
- Identify biomarkers predicting response or resistance.
- Analyze patient-reported outcomes related to quality of life.
3. Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma
Primary Objective:
- Assess the safety and tolerability of the IFx-Hu2.0 vaccine.
Secondary Objectives:
- Evaluate immune responses (systemic and intralesional).
- Measure preliminary antitumor activity (RECIST 1.1 or iRECIST).
Exploratory Objectives:
- Identify biomarkers predicting response.
- Analyze changes in the tumor microenvironment.
4. A Phase-2 Open-label Multicentre Study of Single Agent Enzastaurin in Patients with Relapsed Cutaneous T-cell Lymphoma
Primary Objective:
- Measure the overall response rate (ORR) of Enzastaurin in patients with relapsed CTCL.
Secondary Objectives:
- Assess progression-free survival (PFS) and duration of response (DoR).
- Evaluate overall survival (OS).
- Determine the safety and tolerability of Enzastaurin.
- Explore biomarkers associated with response.
5. Evaluating the Efficacy and Safety of Pembrolizumab Versus Placebo in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled TrialPrimary Objective:
- Assess the effectiveness of pembrolizumab compared to placebo in prolonging progression-free survival (PFS).
Secondary Objectives:
- Measure overall survival (OS).
- Evaluate the objective response rate (ORR) and duration of response (DoR).
- Assess the safety profile of pembrolizumab.
Exploratory Objectives:
- Explore the relationship between PD-L1 levels and treatment effectiveness.
- Analyze quality of life (QoL) using patient-reported data.