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Researchers are evaluating calderasib, alone or combined with cetuximab, to treat advanced solid tumors in people with the KRAS G12C mutation. This phase 2, open-label study aims to learn how many patients respond to these treatments and to assess their safety and tolerability. The study is tumor-agnostic, meaning it includes various solid tumors except colorectal cancer, focusing on those that have progressed after standard treatments. Participants will be randomly assigned to receive either calderasib alone or calderasib combined with cetuximab. Calderasib is taken orally, and cetuximab is given by intravenous infusion every two weeks. There is no maximum number of treatment cycles, and participants continue treatment until they meet specific criteria for stopping. During the study, participants will be closely monitored for tumor response, adverse events, and treatment discontinuation due to side effects over up to approximately 76 months. Researchers will measure outcomes such as objective response rate, progression-free survival, duration of response, overall survival, and safety. The study begins with screening and continues with regular treatment visits and follow-ups to collect these data.

Researchers are evaluating new treatments for relapsed high-grade serous ovarian cancer, a fast-growing cancer that starts in the cells covering the ovaries, lining of the belly, or fallopian tubes. This cancer has returned after prior treatment, and the study aims to understand how well the antibody drug conjugate raludotatug deruxtecan (R-DXd) works when combined with other anticancer agents. The study is a Phase 1b/2 trial designed to assess the safety and effectiveness of these combinations in patients who have relapsed after platinum-based chemotherapy. The study has two parts: Part 1 tests increasing doses of R-DXd combined with chemotherapy drugs carboplatin or paclitaxel, or with bevacizumab and pembrolizumab, to find the safest and most effective dose. Part 2 uses the recommended dose from Part 1 to further evaluate these combinations. Treatment cycles occur every 3 weeks, with up to six cycles of chemotherapy drugs and up to 35 cycles of pembrolizumab. Participants continue receiving R-DXd until their disease progresses or treatment is stopped. Participants will undergo regular assessments including scans to measure tumor response, monitoring for side effects, and evaluations of overall health. The main outcomes are safety measures like dose-limiting toxicities and adverse events, as well as how many participants experience shrinkage or disappearance of tumors. The study may last up to about three years, with ongoing monitoring of treatment effects and safety throughout the trial period.

Researchers are evaluating the safety, effectiveness, best dose, and how the body processes BNT326 when used alone or combined with other immunotherapy drugs in adults with advanced solid tumors. These tumors are either metastatic, recurrent without further treatment options, or have relapsed after previous therapy. The study includes patients with different types of advanced cancers such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. In Part 1, participants receive BNT326 alone across several cancer-specific groups, including cutaneous melanoma, non-small cell lung cancer (with or without specific mutations), rare melanomas, advanced tumors, and cervical cancer. Part 2 evaluates BNT326 alone or combined with another immunotherapy drug called pumitamig. Participants are assigned to different dose levels, sometimes randomly, depending on their cancer type and group. The study includes a screening period, treatment for up to 24 months or until progression or other reasons, and follow-up periods. During the study, participants undergo assessments including tumor tissue sampling, monitoring of treatment side effects, blood tests to measure drug levels, and evaluations of tumor response and survival. Safety is closely followed up to 42 or 90 days after treatment ends, with longer-term monitoring for up to 38 months (Part 1) or 48 months (Part 2). Participants' overall response rates, adverse events, and pharmacokinetics are key outcomes. The study is sponsored by BioNTech SE and includes open-label, adaptive design across two phases.

Researchers are evaluating ALX2004, an antibody drug conjugate targeting EGFR, in adults with advanced or metastatic selected solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer. This Phase 1, open-label, multicenter study aims to find the appropriate dose and assess safety and response in participants who have previously received treatment for these cancers. The study is sponsored by ALX Oncology Inc. and plans to enroll up to 170 patients. The study includes three parts: Phase 1a Dose Escalation with increasing doses of ALX2004 to find a safe dose, Phase 1a Dose Exploration where selected doses are further tested in specific tumor types, and Phase 1b Dose Expansion where the recommended dose is given to more patients. ALX2004 is given by intravenous infusion, and dosing is adjusted depending on the study phase and tumor type. Participants will have regular assessments including safety monitoring for dose limiting toxicities and adverse events, tumor response evaluations using RECIST criteria, and measurement of drug levels in the blood. Follow-up can last up to two years from the first dose. The study records outcomes like overall response rate, progression-free survival, and overall survival to understand ALX2004's effects. The total duration of participation depends on the treatment phase and follow-up period.

Researchers are evaluating MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adults with advanced breast cancer that cannot be cured by other treatments. This first-in-human study aims to understand the safety, appropriate dose, and effects of MEN2312 alone and in combination with another drug called elacestrant. The trial is sponsored by Stemline Therapeutics, Inc. and focuses on participants whose cancer has specific genetic changes and who have had prior hormone therapy and other treatments. Participants are randomly assigned to receive either MEN2312 alone or MEN2312 combined with elacestrant, both given as oral tablets. The study includes a phase to determine the recommended dose of MEN2312 and to observe any dose-limiting side effects. Treatment continues with close monitoring for up to approximately 7 months, with assessments extending to around 9 months for certain outcomes. During the study, participants will undergo evaluations to track safety, response to treatment, and how the drugs behave in the body. Researchers will measure outcomes such as dose-limiting toxicities, overall response rate, duration of response, progression-free survival, and overall survival. Laboratory tests will assess drug levels and excretion, and participants will be followed for several months after treatment to monitor effects and safety.

Researchers are studying the safety, tolerability, and how the body processes and responds to IMP1734, a PARP1 selective inhibitor, in adults with advanced solid tumors. This trial focuses on patients with recurrent or metastatic cancers such as breast, ovarian, and prostate cancer. The study aims to find the best dose and understand early effects of IMP1734 when used alone, addressing treatment options for these advanced cancers. The trial includes two parts: Part 1 involves increasing doses of IMP1734 alone to find the maximum tolerated or achievable dose. This includes patients with metastatic prostate cancer, ovarian, and breast cancer. Part 2 will explore the best dose for future studies. IMP1734 is given as oral tablets daily, except during a single-dose period. Participants may be involved for up to three years after their first treatment. During the study, participants will have regular assessments for safety including monitoring adverse events and tolerability. Researchers will evaluate pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug's effects). They will also measure tumor response and other clinical outcomes. Follow-up will continue up to three years to monitor long-term effects and gather comprehensive data on IMP1734.

Researchers are evaluating BHV-1530 in adults with advanced or metastatic solid tumors in this Phase 1, first-in-human, open-label, multicenter study. The study aims to assess the safety and appropriate dosing of BHV-1530 while monitoring patients who have progressed after or are intolerant to standard therapies. It focuses on tumors such as urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, including those with FGFR3 alterations or high FGFR3 expression. Participants receive BHV-1530 as an intravenous infusion on Day 1 of each 21-day cycle. The study includes dose-escalation, dose-expansion, and dose-confirmation phases to determine the recommended dose for later trials. Treatment continues under close observation to evaluate adverse events and clinical responses over approximately 48 months. During the study, participants undergo regular assessments including tumor measurements by RECIST 1.1 criteria, performance status evaluations, blood tests, liver and kidney function tests, and pregnancy tests if applicable. Researchers will track adverse events, clinical benefit rates, response durations, progression-free survival, and drug concentration levels in the blood. Safety monitoring and follow-up continue through the study completion period, which is estimated to average 48 months per participant.

Researchers are evaluating IAM1363, an investigational drug, in a Phase 1/1b open-label study involving participants with advanced cancers that have HER2 alterations. The study aims to assess the safety and early effects of IAM1363 in these patients, including those with brain metastases. This trial includes multiple parts focusing on dose escalation, dose optimization, expansion in specific tumor types, and combination with other anti-cancer treatments. The study has four parts: Part 1 involves escalating doses of IAM1363 as a monotherapy to find the maximum tolerated dose. Part 2 optimizes the dose based on safety and preliminary efficacy results. Part 3 expands to tumor-specific groups using the selected dose. Part 4 studies IAM1363 combined with other cancer drugs. Treatments are given orally in 14- or 21-day cycles. Participants will undergo evaluations including monitoring for dose-limiting toxicities, adverse events, and laboratory abnormalities. Researchers will measure responses in tumors and the central nervous system, pharmacokinetics, and treatment modifications. Follow-up will continue through study completion, estimated at about 46 months. Safety is closely monitored during and after treatment, with assessments of heart function and other clinical measures.

Researchers are evaluating BHV-1510, a Trop-2 directed antibody-drug conjugate, alone and combined with cemiplimab in adults with previously treated, advanced solid tumors that are incurable or have no standard therapies left. This Phase 1/2 open-label study aims to assess safety, tolerability, and preliminary effectiveness in this population, including determination of recommended doses and maximum tolerated doses of BHV-1510. The study includes two parts: Phase 1 dose escalation to test BHV-1510 alone and with cemiplimab, and Phase 2 dose expansion to further assess response rates and safety. BHV-1510 is given intravenously on various schedules, including every 2 or 3 weeks, sometimes with cemiplimab infusions every 3 weeks. The combination dosing regimens vary, with cemiplimab given at 350 mg on Day 1 or Day 1 and Day 8 every 3 weeks. Participants will undergo regular safety assessments, including monitoring adverse events and laboratory tests. Researchers will measure BHV-1510 levels in blood and evaluate tumor response using imaging and standard criteria. The study may last up to about 47 months, with ongoing follow-up to assess duration of response, progression-free survival, overall survival, and other clinical outcomes. Safety and tolerability will be closely monitored throughout the study.

Researchers are studying TRI-611, an oral ALK molecular glue degrader, to learn about its safety, recommended dose, and how it works against ALK-positive non-small cell lung cancer (NSCLC) in adults. This Phase 1/2 trial aims to find the best dose for further studies and evaluate the antitumor activity of TRI-611 in different groups of patients based on their prior treatments with ALK tyrosine kinase inhibitors (TKIs). The study has two parts. The first part focuses on escalating doses of TRI-611 to determine the maximum tolerated dose and recommended phase 2 dose. The second part involves three groups of participants who have received different previous ALK TKI treatments, including lorlatinib and neladalkib, to explore the drug's antitumor effects. Participants will take TRI-611 continuously as long as their disease does not progress. Participants will visit the clinic about seven times during the first three months and then once every 28-day cycle afterward. They are asked to keep a diary of their medication intake. Researchers will monitor safety by tracking treatment-emergent adverse events and measure how well the cancer responds using objective response rates and depth of response. The study includes long-term follow-up for up to five years to observe response duration, disease control, survival, and effects on the central nervous system.