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Also known as JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2, JNJ-101556143 Formulation 3
JNJ-101556143 · 2 trials · 2 indications
Confirmed overall response, is defined as having either confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) prior to any subsequent anti-cancer therapy.
| Arm | Type | Description |
|---|---|---|
| JNJ-101556143 | EXPERIMENTAL | Participants will receive JNJ-101556143 orally once daily in a 28-day treatment cycle until confirmed radiographic progression by blinded independent central review (BICR) or unequivocal clinical progression, or any other protocol-defined discontinuation criteria is met. |
| JNJ-101556143 Phase 1 Part 1 - Dose Escalation | EXPERIMENTAL | Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) |
| JNJ-101556143 Phase 1 Part 2 - Formulation Exploration | EXPERIMENTAL | Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) |
| JNJ-101556143 Phase 2 Part 1 - Dose Optimization | EXPERIMENTAL | Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) |
| Phase 2 Part 2A - SOAR | EXPERIMENTAL | Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) |
| Phase 2 Part 2B - HSPC Expansion | EXPERIMENTAL | Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) |
| Phase 2 Part 2C - HSPC Expansion | EXPERIMENTAL | Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) |
| Phase 2 Part 2D - HSPC Expansion | EXPERIMENTAL | Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) |
| Name | Type | Description |
|---|---|---|
| JNJ-101556143 | DRUG | Participants will receive JNJ-101556143 orally. |
| JNJ-101556143 Formulation 1 | DRUG | Experimental: Oral JNJ-101556143 |
| JNJ-101556143 Formulation 2 | DRUG | Experimental: Oral JNJ-101556143 |
| JNJ-101556143 Formulation 3 | DRUG | Experimental: Oral JNJ-101556143 |
Inclusion Criteria: * Have histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma, large cell neuroendocrine carcinoma, or sarcoma of the prostate is disallowed * Progressive me...
JNJ-101556143 is an investigational small molecule developed by Johnson & Johnson for the treatment of metastatic prostate cancer and prostatic neoplasms. It is in Phase 1 clinical development and is being evaluated in clinical trials for patients with advanced prostate cancer.
JNJ-101556143 is being studied for use in metastatic prostate cancer and prostatic neoplasms. It is an investigational therapy, meaning it has not been approved by regulatory authorities for any indication and is available only through clinical trials.
JNJ-101556143 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company is responsible for the clinical development program of this small molecule in oncology.
JNJ-101556143 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for commercial use. It is currently being evaluated in clinical trials for metastatic prostate cancer.
JNJ-101556143 is being evaluated in two recruiting clinical trials: NCT07832292, a Phase 2 study in participants with metastatic prostate cancer, and NCT06800313, a Phase 1 study in patients with metastatic prostate cancer. Both trials are currently active and enrolling male participants aged 18 years and older.
JNJ-101556143 is also known as HLD-0915, as referenced in the Phase 1 trial NCT06800313. Additionally, the drug has been described in three formulations: JNJ-101556143 Formulation 1, Formulation 2, and Formulation 3. These names refer to the same investigational compound.