PRE-ISPY Phase I/II Oncology Platform Program

PRE-ISPY Phase I/II Oncology Platform Program is a phase 1/2, interventional study registered as NCT05868226 by QuantumLeap Healthcare Collaborative, with a registry enrolment figure of 280 participants, started 2023-02-15 and due to reach its primary completion in 2030-12-30. Interventions recorded: ALX148; Fam-Trastuzumab Deruxtecan-Nxki; Zanidatamab; Tucatinib; TTX-MC138. Conditions listed: HER2-positive Breast Cancer; Metastatic Cancer; Metastatic Breast Cancer; Metastatic; HER2-positive Metastatic Breast Cancer; HER2 Mutation-Related Tumors; HER-2 Protein Overexpression; HER2-negative Breast Cancer; Triple Negative Breast Cancer; HR Positive; Hormone Receptor-positive Breast Cancer; Estrogen Receptor Positive Tumor; Progesterone Receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma; Solid Tumor; Solid Tumor, Adult; Solid Carcinoma; HER2 Low Breast Cancer; HER2 Low Breast Carcinoma; ER Positive Breast Cancer; PR-positive Breast Cancer; Minimal Residual Disease; Colo-rectal Cancer; Colon Cancer; Rectal Cancer; ctDNA Monitoring; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Neoplasm, Residual; Adenocarcinoma of Colon; Adenocarcinoma. Primary outcome: Incidence of Adverse Events related to the treatment; For Phase Ib Part 1 study design: Incidence of Dose Limiting Toxicities (DLTs) at each dose level; For select drug arms, Maximum Tolerated Dose (MTD). Colorectal eligibility wording from the registry: "Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation". Sites: United States. No results are recorded here; the registry entry is the source.