{"entity":{"id":"nct05868226","kind":"trial","name":"PRE-ISPY Phase I/II Oncology Platform Program","aka":["PRE-ISPY"],"tldr":"A phase 1/2 trial of evorpacept, zanidatamab and tucatinib in colorectal cancer, run by QuantumLeap Healthcare Collaborative, now recruiting.","summary":"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.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05868226","url":"https://clinicaltrials.gov/study/NCT05868226"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","mrd-testing"],"targets":[],"drugs":["evorpacept","zanidatamab","tucatinib"],"companies":["alx-oncology","jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05868226","phase":"1/2","setting":"PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/II Platform Trial","sponsor":"QuantumLeap Healthcare Collaborative","enrolled":280,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05868226/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"her2-amplified-colorectal","kind":"cancer","name":"HER2-amplified colorectal cancer","route":"/cancers/her2-amplified-colorectal/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"her2-tyrosine-kinase-inhibitors","kind":"technology","name":"HER2 tyrosine kinase inhibitors","route":"/technologies/her2-tyrosine-kinase-inhibitors/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"evorpacept","kind":"drug","name":"Evorpacept","route":"/drugs/evorpacept/"},{"id":"tucatinib","kind":"drug","name":"Tucatinib","route":"/drugs/tucatinib/"},{"id":"zanidatamab","kind":"drug","name":"Zanidatamab","route":"/drugs/zanidatamab/"}],"company":[{"id":"alx-oncology","kind":"company","name":"ALX Oncology","route":"/companies/alx-oncology/"},{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}