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Researchers are evaluating the safety, tolerability, pharmacokinetics, and clinical activity of RMC-6236, an oral drug targeting specific RAS mutations, in adults with advanced solid tumors. This Phase 12, multicenter, open-label study aims to find the maximum tolerated dose and recommended dose for further study among patients with tumors harboring particular KRAS, NRAS, or HRAS mutations. RMC-6236 selectively inhibits active RAS forms, which are involved in cancer growth. The study includes a dose exploration phase open to any advanced solid tumor with KRAS p.G12 mutations, followed by dose expansion or optimization in groups with specific tumor types and RAS mutations, such as non-small cell lung cancer, pancreatic ductal adenocarcinoma, colorectal cancer, melanoma, and gynecological cancers. Participants receive escalating doses of RMC-6236 taken orally. The study evaluates dose-limiting toxicities and monitors drug levels in the blood over several weeks. Participants will undergo safety assessments including monitoring adverse events, lab tests, and vital signs for up to 2.5 years, along with evaluations of response rates, disease control, and progression-free survival. The study tracks how the drug is processed in the body and records any treatment-related toxicities. Participants may be followed long-term to observe the duration of response and overall clinical outcomes.

Researchers are investigating BIO-106, a new antibody-drug conjugate targeting Trop-2, alone and combined with pembrolizumab, a PD-1 blocking antibody, in patients with advanced solid tumors or cancers that have progressed despite standard treatments or cannot tolerate them. This open-label Phase 12 trial aims to find the best tolerated dose in Phase 1 and evaluate preliminary effectiveness in Phase 2 for patients with significant unmet medical needs. In Phase 1, patients receive increasing doses of BIO-106 alone or with pembrolizumab to determine the maximum tolerated dose or recommended dose for Phase 2. Phase 2 involves dose expansion to assess anti-tumor activity using measures like response rates and survival. Participants receive treatments according to their assigned group, and dosing schedules follow the study design without blinding or placebo. Participants undergo regular monitoring for adverse events, dose-limiting toxicities, and antibody formation against BIO-106. Effectiveness is measured by tumor response, disease control, duration of response, progression-free survival, and overall survival over one to two years. Safety and pharmacokinetics data are collected throughout, with close evaluation of serious events and special interest adverse events. The study expects to last until April 2027.

Researchers are evaluating the safety, tolerability, and antitumor activity of STC-15, a METTL3 inhibitor, both alone and in combination with toripalimab, an anti-PD-1 therapy, in people with advanced unresectable or metastatic tumors. This early phase oncology trial includes a Phase 1b dose escalation study and a Phase 2 monotherapy part focusing on selected relapsed sarcoma subtypes such as dedifferentiated liposarcoma and leiomyosarcoma. The study aims to understand how these treatments perform in these difficult-to-treat cancers. Participants in the Phase 1b part receive STC-15 combined with toripalimab in 21-day treatment cycles, focusing on dose escalation to determine safety and tolerability. In the Phase 2 monotherapy part, participants with specific sarcoma subtypes receive STC-15 alone in 21-day cycles. Both parts are open-label and non-randomized, conducted at multiple centers. The trial evaluates both combination therapy and monotherapy separately to understand their effects. During the study, participants undergo regular assessments including imaging to measure tumor response, laboratory tests to monitor drug levels and organ function, and safety evaluations. The primary outcomes include safety and tolerability over 6 months, and antitumor activity for both combination and monotherapy cohorts. Participants are followed for up to 6 months to assess treatment effects and side effects. The trial is led by STORM Therapeutics LTD and aims to provide important information about these experimental therapies.

Researchers are evaluating the safety, pharmacokinetics, and preliminary effectiveness of NST-628, an oral drug targeting the MAPK pathway, in adults with advanced solid tumors that have specific genetic mutations and have exhausted standard treatments. This Phase 1, open-label, multi-center study includes patients with tumors dependent on the MAPK pathway, such as melanoma and glioma, aiming to find a suitable dose and observe tumor responses. The study has two parts Part A involves dose escalation where increasing doses of NST-628 are given once daily in 28-day cycles to determine the maximum tolerated dose and the recommended dose for expansion. Part B involves dose expansion with several cohorts of patients harboring specific MAPK pathway mutations receiving the recommended dose to further assess safety and tumor response. Dose adjustments may be made based on observed effects. Participants will undergo regular assessments including safety evaluations, tumor response measurements using standardized criteria, and pharmacokinetic analyses throughout the study, which lasts about one year on average for primary outcomes and up to two years for survival monitoring. Tumor tissue samples are required, and patients will be followed until the last visit of the final participant. Safety, tumor response, progression-free survival, overall survival, and drug behavior in the body are key outcomes measured.

Researchers are evaluating the safety and effectiveness of KQB365, alone and in combination with cetuximab or KQB198, in adults with advanced solid tumor cancers that have specific KRAS G12C or G12S mutations. The trial aims to find the safe dose of KQB365, see if it decreases tumor size, and understand how the drug behaves in the body. This study focuses on patients with unresectable or metastatic tumors who have no curative treatment options available. Participants will receive weekly infusions of KQB365 either alone or combined with intravenous cetuximab or oral KQB198. The study includes a dose escalation phase to find the recommended dose, followed by dose expansion phases to evaluate treatment effects. The trial is open-label and non-randomized, with multiple treatment groups receiving different drug combinations to assess safety and response. During the trial, participants will visit the clinic about nine times in the first six weeks and then weekly thereafter. Researchers will monitor adverse events, dose tolerability, tumor response using RECIST criteria, and drug levels in the blood. Outcome measures include the number of side effects, recommended phase 2 dose, objective response rate, survival, and disease control. Monitoring continues for up to 35 months to assess long-term safety and treatment effects.

Researchers are conducting a Phase IaIb open-label study to evaluate the safety and pharmacokinetics of ROSE12 alone and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study includes three parts dose escalation, biopsy for biomarker evaluation, and expansion in selected tumor types. The goal is to find the maximum tolerated dose and recommended dose, as well as to assess safety and preliminary anti-tumor activity. Participants will receive ROSE12 as an intravenous infusion at increasing doses, either alone or combined with atezolizumab or pembrolizumab, also given by intravenous infusion. Serial biopsies will be performed in some parts to study biomarkers. The study consists of multiple parts including dose-escalation phases, biopsy phases, and expansion phases where patients receive recommended doses of the drug combinations. During the study, participants will have safety and tolerability monitored from screening through treatment and follow-up, for up to approximately 43 months. Researchers will measure pharmacokinetics by monitoring serum concentrations of the drugs and assess preliminary anti-tumor effects. Biomarker evaluations and immunogenicity assessments will also be conducted. Participants will have regular visits for infusions, biopsies, and safety assessments throughout the study period.

Researchers are evaluating the safety and antitumor activity of the drug INV-9956 in adult men with advanced metastatic castration resistant prostate cancer. This study is conducted in two parts Phase 1 focuses on finding the right dose and assessing safety, while Phase 2 aims to confirm safety and explore how well the drug works in patients with different androgen receptor gene statuses. Participants receive INV-9956 along with dexamethasone and fludrocortisone acetate. In Phase 1, dose levels are gradually increased using a careful monitoring process to find the maximum tolerated dose and recommended dose range. Phase 2 includes two groups one with mutated androgen receptor cancer and one with wild-type androgen receptor cancer, to further evaluate the drugs effects. During the study, participants will undergo various assessments including safety evaluations, blood tests for drug concentration and hormone levels, and imaging to track cancer progression. The main outcomes measured are maximum tolerated dose, radiographic progression-free survival, and overall response rate over 12 months. The study also monitors side effects and drug behavior in the body to better understand treatment effects and safety.

Researchers are evaluating the safety and dosing of COM503, given alone or with zimberelimab, in adults with advanced solid tumors. This first-in-human trial aims to find the maximum tolerated dose and recommended phase 2 dose of COM503 as both monotherapy and combined with zimberelimab. It focuses on advanced solid malignancies where standard treatments have failed or are unsuitable. The study includes several parts dose escalation of COM503 alone, dose escalation of COM503 combined with a fixed dose of zimberelimab, and dose expansion phases for both the monotherapy and combination therapy. Participants receive COM503 andor zimberelimab via intravenous infusion according to the assigned study part. During the trial, participants will undergo evaluations to monitor safety and tolerability from the first dose until 90 days after the last dose or the start of new anticancer therapy. Imaging with CT or MRI will assess tumor response. Researchers will track adverse effects, dosing limits, and overall safety profile over the study period. The trial is expected to last until November 2027.

Researchers are evaluating the safety, effectiveness, and how the body processes IDE892 when used alone or combined with other drugs like IDE397 in adults with advanced solid tumors that have a specific genetic change called MTAP deletion. This study focuses on participants whose cancer has progressed after standard treatment and aims to address a significant medical need by targeting vulnerabilities in tumors with this genetic deletion. Participants will receive IDE892 alone or combined with IDE397, an oral drug that blocks MAT2A, to improve treatment impact while maintaining safety. The study includes dose escalation phases to find the right dose and expansion phases to further assess the treatments effects. Different groups include those with various solid tumors and those with non-small cell lung cancer NSCLC, with treatment cycles lasting 21 days. During the study, participants will have blood and tumor tissue samples collected for biomarker testing and monitoring. Researchers will assess side effects, how well the drug is tolerated, tumor response, and drug levels in the body over approximately two years. Visits include regular safety checks and scans to evaluate tumors. Participants must comply with scheduled visits, treatment plans, and tests throughout the study.

Researchers are evaluating the safety and effectiveness of HLD-0117 as a single treatment in women with estrogen receptor positive ER metastatic or locally advanced breast cancer that has worsened after previous therapies. This open-label Phase 1 trial aims to find the best tolerated dose and recommended dose levels of HLD-0117 by studying its effects and how the body processes the drug. The study involves patients who have experienced progression following at least one prior systemic treatment. Participants will receive oral HLD-0117 as a single agent in 28-day treatment cycles. The study uses a dose-escalation design with small patient groups to determine safe dosage levels, potentially enrolling more patients at certain doses to better understand tolerability and treatment effects. Treatment continues until disease progression or other reasons require stopping, such as side effects or withdrawal of consent. During the study, patients will undergo regular monitoring including physical exams, lab tests, ECGs, and imaging to evaluate safety and response. Researchers will assess dose limiting toxicities, adverse events, and clinical changes over 28 days, and measure tumor response and disease control over several weeks. Participants are expected to provide tumor biopsies at baseline and during treatment if possible. The total duration includes treatment cycles and follow-up to monitor outcomes and safety.