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The study was terminated by Sponsor for strategic reasons.
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This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a and Phase 1b | Experimental | PHN-010 is administered intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHN-010 | Drug | PHN-010 is an ADC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (Phase 1a) | 18 months | |
| Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) | 18 months | |
| Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) | 18 months | |
| Overall response rate (ORR) (Phase 1b) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response (BOR) (Phase 1a and 1b) | 36 months | |
| Disease control rate (DCR) (Phase 1a and 1b) | 36 months | |
| Progression free survival (PFS) (Phase 1a and 1b) |
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Key Inclusion Criteria:
Has histologically confirmed, advanced/metastatic:
Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.
Has measurable disease.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has adequate organ function.
Has available tumor tissue sample at screening (either an archival specimen collected ≤ 3 years prior to the date of informed consent or fresh biopsy material).
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Orlando | Florida | 32804 | United States | ||
| Dana Farber Cancer Institute |
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| 36 months |
| Time to response (TTR) (Phase 1a and 1b) | 36 months |
| Overall survival (OS) (Phase 1a and 1b) | 36 months |
| Cancer antigen 125 (CA-125) response (Phase 1a and 1b) | 36 months |
| Time to CA-125 response (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, Cmax of free payload (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, Tmax of free payload (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, AUC of total antibody (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, AUC of total free payload (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b) | 36 months |
| Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b) | 36 months |
| Concentration of anti-drug antibodies (Phase 1a and 1b) | 36 months |
| Type, incidence and severity of AEs and SAEs (Phase 1b) | 18 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| NEXT - San Antonio | San Antonio | Texas | 78229 | United States |
| NEXT - Virginia | Fairfax | Virginia | 22031 | United States |
| University of Washington/Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002577 | Uterine Cervical Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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