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The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTA3263 monotherapy | Experimental | ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 in combination with cetuximab | Experimental | ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 in combination with mFOLFOX6 plus cetuximab | Experimental | ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, and oxaliplatin (mFOLFOX6) and cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 in combination with pembrolizumab | Experimental | ALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 in combination with pembrolizumab plus chemotherapy | Experimental | ALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTA3263 | Drug | Oral ALTA3263 tablets will be administered at a protocol-defined dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants that experience treatment-emergent adverse events (TEAEs). | Up to 39 months |
| Dose Limiting Toxicities | Number of participants with Dose Limiting Toxicities (DLTs). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax | Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alterome Clinical Trial Contact Center | Contact | 619-768-8189 | clinical.trials@alterome.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Medical Director | Alterome Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Orlando | Florida | 32827 | United States | |
| Research Site |
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|
| ALTA3263 in combination with mFOLFIRINOX | Experimental | ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 in combination with mFOLFIRINOX plus cetuximab | Experimental | ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 in combination with GnP | Experimental | ALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 in combination with GnP plus cetuximab | Experimental | ALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| ALTA3263 Midazolam DDI Substudy | Experimental | ALTA3263 and midazolam will be administered at a protocol defined schedule |
|
| cetuximab | Drug | Cetuximab injection for IV use will be administered at a protocol-defined dose |
|
| mFOLFOX6 | Drug | modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose |
|
| Pembrolizumab | Drug | Pembrolizumab injection for IV use will be administered at a protocol-defined dose |
|
| Pemetrexed + Cisplatin /Carboplatin | Drug | Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose |
|
| mFOLFIRINOX | Drug | modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose |
|
| GnP | Drug | gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose |
|
| Midazolam | Drug | Oral midazolam will be administered at a protocol-defined dose |
|
Tmax
| Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose |
| Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt) | AUCt | Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose |
| Terminal Half-Life (t1/2) | t1/2 | Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose |
| Objective Response Rate (ORR) | Assess per RECIST 1.1 | Up to 39 months |
| Duration of Response (DOR) | Assess per RECIST 1.1 | Up to 39 months |
| Progression-Free Survival (PFS) | Assess per RECIST 1.1 | Up to 39 months |
| Overall Survival (OS) | Assess per RECIST 1.1 | Up to 39 months |
| Recruiting |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Research Site | Recruiting | Boston | Massachusetts | 02115 | United States |
| Research Site | Recruiting | St Louis | Missouri | 63110 | United States |
| Research Site | Recruiting | New York | New York | 10016 | United States |
| Research Site | Recruiting | New York | New York | 10032 | United States |
| Research Site | Recruiting | Durham | North Carolina | 27710 | United States |
| Research Site | Recruiting | Nashville | Tennessee | 37203 | United States |
| Research Site | Recruiting | Houston | Texas | 77030 | United States |
| Research Site #2 | Recruiting | San Antonio | Texas | 78229 | United States |
| Research Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Research Site | Recruiting | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009371 | Neoplasms by Site |
| D002277 | Carcinoma |
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
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