# PRE-ISPY Phase I/II Oncology Platform Program

Source: https://onco.cc/trials/nct05868226/  
OnCo record `nct05868226` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Also known as: PRE-ISPY
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT05868226: https://clinicaltrials.gov/study/NCT05868226

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [HER2-amplified colorectal cancer](https://onco.cc/cancers/her2-amplified-colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [HER2 tyrosine kinase inhibitors](https://onco.cc/technologies/her2-tyrosine-kinase-inhibitors/), [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Evorpacept](https://onco.cc/drugs/evorpacept/), [Tucatinib](https://onco.cc/drugs/tucatinib/), [Zanidatamab](https://onco.cc/drugs/zanidatamab/)
- companies: [ALX Oncology](https://onco.cc/companies/alx-oncology/), [Jazz Pharmaceuticals](https://onco.cc/companies/jazz/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct05868226.json