> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-study-medicine-alta3263-in-adults-cebf4407-2cb9-41e1-b239-fe31bc450ce0 > Record changed: 2026-10-13 # A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations NCT06835569 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) Participants 448 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) Lead sponsor Alterome Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) Start date 2025-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Title and summary **Summary** The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Short title** A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Official title** A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Dates **Completion date** 2029-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **First posted** 2025-02-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Registry last updated** 2026-06-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Primary completion date** 2029-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Start date** 2025-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Size and sites **Participants** 448 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Planned participants** 448 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Lead sponsor** Alterome Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Identifiers **Registry ID** NCT06835569 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **ClinicalTrials.gov ID** NCT06835569 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Outcomes ### Primary outcomes 1. Adverse Events Timeframe: Up to 39 months Number of participants that experience treatment-emergent adverse events (TEAEs). 2. Dose Limiting Toxicities Timeframe: 21 days Number of participants with Dose Limiting Toxicities (DLTs). ### Secondary outcomes 1. Maximum Observed Plasma Concentration (Cmax) Timeframe: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose Cmax 2. Time to Reach Maximum Observed Plasma Concentration (Tmax) Timeframe: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose Tmax 3. Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt) Timeframe: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose AUCt 4. Terminal Half-Life (t1/2) Timeframe: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose t1/2 5. Objective Response Rate (ORR) Timeframe: Up to 39 months Assess per RECIST 1.1 6. Duration of Response (DOR) Timeframe: Up to 39 months Assess per RECIST 1.1 7. Progression-Free Survival (PFS) Timeframe: Up to 39 months Assess per RECIST 1.1 8. Overall Survival (OS) Timeframe: Up to 39 months Assess per RECIST 1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test. - Unresectable or metastatic disease. - Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function ### Exclusion criteria - Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol - Known condition that prohibits the ability to swallow or absorb an oral medication. Other inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Sites - Research SiteOrlando, United StatesRecruiting - Research SiteBoston, United StatesRecruiting - Research SiteBoston, United StatesRecruiting - Research SiteSt Louis, United StatesRecruiting - Research SiteNew York, United StatesRecruiting - Research SiteNew York, United StatesRecruiting - Research SiteDurham, United StatesRecruiting - Research SiteNashville, United StatesRecruiting - Research SiteHouston, United StatesRecruiting - Research Site #2San Antonio, United StatesRecruiting - Research SiteSan Antonio, United StatesRecruiting - Research SiteFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06835569) ## Related records ### Drugs (7) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Midazolam](https://trialight.com/data/asset/midazolam-1bd7ce5f-a598-4c40-a36b-e990c47207ef.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [Alterome Therapeutics, Inc.](https://trialight.com/data/company/alterome-therapeutics-inc-94bc3fa2-c380-42b3-bea3-3d60f17a0a09.md) ### Conditions (7) - [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) - [Colonic neoplasm](https://trialight.com/data/condition/colonic-neoplasm-be61bc3a-c82f-5b84-a20f-3f9931cfcc77.md) - [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) ### Targets (21) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md) - [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md) - [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md) - [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md) - [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) - [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md) - [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md) - [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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