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A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors
This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion. The study will enroll previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). Up to 170 patients are expected to be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALX2004 Phase 1a (Dose Escalation) | Experimental | ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase |
|
| ALX2004 Phase 1a (Dose Exploration) | Experimental | ALX2004 will be administered. All or a subset of tumors tested in dose escalation will enroll into 1 or 2 dose levels during the dose exploration phase |
|
| ALX2004 Phase 1b (Dose Expansion) | Experimental | ALX2004 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALX2004 | Drug | ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Incidence of dose limiting toxicities (DLTs) | Phase 1a: Number and proportion of participants enrolled in the dose escalation phase who experience dose-limiting toxicities (DLTs), received at least one dose of ALX2004 and completed the DLT evaluation | Up to 28 days |
| Phase 1a: Incidence of treatment emergent adverse events | Phase 1a: Adverse Events as characterized by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness, and relationship to the study drug in order to establish the RDE. Laboratory abnormalities as characterized by type, frequency, severity and timing | Up to 2 years from first dose |
| Phase 1b: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1 | Phase 1b: ORR is defined as proportion of participants whose BOR is complete response (CR) or partial response (PR) | Up to 2 years from first patient dosed in dose expansion phase |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a and 1b: Maximum Concentration (Cmax) | To evaluate the Cmax of ALX2004 | Up to 2 years |
| Phase 1a and 1b: Time of Maximum Plasma Concentration (Tmax) | To evaluate the Tmax of ALX2004 |
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Inclusion Criteria:
Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent
HNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting
NSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting. For participants without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting
ESCC - Received no more than 3 prior lines of therapy in the advanced/metastatic setting
CRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting. For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Athanasios Tsiatis, MD | Contact | 650-466-7125 | info@alxoncology.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALX Center 7 | Recruiting | Tampa | Florida | 33612 | United States | |
| ALX Center 8 |
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The dose escalation and dose exploration portions of the study will be non-randomized. For each tumor type selected for dose expansion, either one or two dose(s) and schedule(s) may be tested. If two doses/schedules are tested, allocation will be randomized.
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| ALX2004 | Drug | ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion |
|
| ALX2004 | Drug | ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion |
|
| Up to 2 years |
| Phase 1a and 1b: Clearance (CL) | To evaluate the clearance of ALX2004 | Up to 2 years |
| Phase 1a and 1b: Area under the concentration time curve (AUC) | To evaluate the AUC of ALX2004 | Up to 2 years |
| Phase 1a and 1b: Terminal elimination half-life (t1/2) | To evaluate the t1/2 of ALX2004 | Up to 2 years |
| Phase 1a: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1 | Phase 1a: ORR is defined as proportion of participants whose BOR is complete response (CR) or partial response (PR) | Up to 2 years from first dose |
| Phase 1a and 1b: Evaluate the immunogenicity of ALX2004 | Measured by the presence of human plasma ADA (Anti-ALX2004 antibodies) | Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase |
| Phase 1b: Incidence of treatment emergent adverse events | AEs as characterized by type, frequency, severity (as graded by the NCI CTCAE v.5.0) timing, seriousness, and relationship to study drug. Laboratory abnormalities as characterized by type, frequency, severity and timing | Up to 2 years from first patient dosed in dose expansion phase |
| Phase 1a and 1b: Progression Free Survival (PFS) | PFS is defined as the time (in months) from the date of the first dose of ALX2004 to the date of the first instance of progressive disease or death | Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase |
| Phase 1a and 1b: Overall Survival (OS) | OS is defined as the time (in months) from the date of the first dose of ALX2004 to the date of death | Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase |
| Phase 1a and 1b: Best Overall Response (BOR) | BOR is defined as the best response reached during the course of the trial from the response categories of CR, PR, SD, PD, and No Response using RECIST v1.1 | Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase |
| Phase 1a and 1b: DCR (Disease Control Rate) | DCR is defined as the proportion of participants whose BOR is PR, CR, or SD | Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase |
| Phase 1a and 1b: Duration of Response (DoR) | DoR is defined as the time (in months) from the first instance of a BOR, of CR/PR until the date of the first instance of progressive disease | Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase |
| Recruiting |
| Farmington Hills |
| Michigan |
| 48334 |
| United States |
| ALX Center 3 | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| ALX Center 6 | Recruiting | Portland | Oregon | 97213 | United States |
| ALX Center 5 | Recruiting | Houston | Texas | 77030 | United States |
| ALX Center 4 | Recruiting | West Valley City | Utah | 84119 | United States |
| ALX Center 2 | Recruiting | Fairfax | Virginia | 22031 | United States |
| ALX Center 1 | Recruiting | Spokane | Washington | 99208 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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 |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D004935 | Esophageal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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