Evaluation of GDC-6036 Monotherapy and Combination Therapy in Advanced or Metastatic Solid Tumors with KRAS G12C Mutation

The primary objective of this study is to evaluate the **safety**, **pharmacokinetics**, and **activity** of GDC-6036 as a single agent and in combination with other anti-cancer therapies in patients with advanced or metastatic solid tumors harboring a **KRAS G12C mutation**. This is clinically relevant as KRAS G12C mutations are known to drive cancer progression, and targeting this mutation could potentially improve treatment outcomes for patients with these types of tumors.

The clinical trial involves a total of **325 participants** diagnosed with **advanced or metastatic solid tumors** harboring the **KRAS G12C mutation**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected based on their diagnosis and the presence of the specific genetic mutation. The trial includes a vulnerable population, indicating that special considerations are in place for their participation. Lifestyle factors such as diet, physical activity, and habits were not specified by the sponsor. The selection criteria for the trial population were not detailed, and no specific inclusion or exclusion criteria were provided.

The clinical trial is designed to evaluate the **safety**, pharmacokinetics, and activity of GDC-6036, both as a single agent and in combination with other anti-cancer therapies, in patients with advanced or metastatic solid tumors harboring a **KRAS G12C mutation**. This study is a Phase 1 trial, which typically involves a small number of participants to assess the initial safety profile and optimal dosing of the investigational drug. The trial follows a randomized, double-blind, controlled design to ensure unbiased results and reliable data collection. The estimated duration of the trial spans from the recruitment start date on November 4, 2020, to the anticipated end date on December 31, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria related to their medical condition and overall health status. Following successful screening, participants will be enrolled in the study and will attend regular follow-up visits to monitor their response to the treatment, assess any adverse effects, and adjust dosages as necessary. These visits are crucial for collecting data on the drug's pharmacokinetics and therapeutic activity. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the trial will vary depending on individual response to the treatment and the progression of the disease. However, participants are generally expected to remain in the study until the end-of-study visit unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, disease progression that warrants alternative treatment, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines and regulatory standards to ensure the safety and well-being of all participants throughout the study duration.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating its primary focus on safety and dosage determination, with preliminary efficacy assessments. The estimated recruitment start date was November 4, 2020, and the trial is projected to conclude by December 31, 2025. Although specific efficacy endpoints are not detailed, typical Phase 1 trials may involve the collection of preliminary data on efficacy parameters such as symptom improvement scores or biomarker levels. These assessments are generally conducted using validated scales or laboratory tests at predetermined intervals throughout the trial duration. The data collected will be analyzed to determine the potential efficacy of the investigational product, contributing to the overall understanding of its therapeutic profile.