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# Crescent Biopharma Targets First-Quarter 2027 Data For CR-001 And Early-2028 Phase 3 Start
- URL: https://www.bullished.co/crescent-biopharma-targets-first-quarter-2027-data-for-cr-001-and-early-2028-phase-3-start-6153f396/
- Published: 2026-10-15T20:37:15.000Z
- Updated: 2026-10-15T20:37:15.000Z
- Description: An 8-K sets readout timing from early 2027 and reports FDA clearance to proceed with a second drug, CR-002.
- Author: Matteo Parrino
- Tags: Earnings, CBIO, Industry: Healthcare

Crescent Biopharma said its cancer antibody CR-001 [finished dose escalation](https://www.sec.gov/Archives/edgar/data/0001253689/000162828026066006/cbio-20261015.htm?ref=bullished.co) and that initial monotherapy data are due in the first quarter of 2027, according to an 8-K filed Thursday. The filing also says the FDA allowed a second drug, CR-002, to proceed to human trials.

## What the 8-K says

CR-001 is a PD-1 x VEGF bispecific antibody being tested in the global Phase 1/2 ASCEND trial. Crescent has completed dose escalation and enrolled participants across several tumor types at sites in the United States, Europe and South Korea.

The first-quarter 2027 readout is to include response rate from a first-line non-small cell lung cancer cohort of up to [12 patients](https://www.sec.gov/Archives/edgar/data/0001253689/000162828026066006/cbio-20261015.htm?ref=bullished.co). It will also carry safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naive and previously treated patients across multiple solid tumor types.

Enrollment has also started in chemotherapy-combination cohorts, with initial data anticipated in mid-2027\. The filing lists seven settings, including first-line lung cancer with paclitaxel and carboplatin or pemetrexed and carboplatin, first-line colorectal cancer with mFOLFOX6, and second-line gastric cancer with paclitaxel.

Pending results and further talks with regulators, Crescent plans to start the first of multiple Phase 3 trials of CR-001 in early 2028.

## The second drug and the China trials

CR-002, a topoisomerase inhibitor antibody-drug conjugate aimed at PD-L1, received FDA allowance to proceed under an Investigational New Drug Application in October 2026\. The Phase 1/2 APOLLO trial is on track to begin in the fourth quarter of 2026 in advanced solid tumors, and initial data are expected in the second half of 2027.

Kelun-Biotech is running China trials of CR-001, also called SKB118, with sac-TMT, a TROP2-directed ADC. Initial data from its Phase 2 lung cancer trial are expected in mid-2027, and a Phase 1/2 trial pairing CR-001 with CR-003 is expected to begin in the first half of 2027.

Kelun-Biotech granted Crescent exclusive rights to CR-003, an integrin-beta 6-targeted ADC, in the United States, Europe and all markets outside Greater China. Crescent plans to use China-generated data to support global development.

## What to watch

Proof-of-concept data for CR-003 from Kelun-Biotech's China trial are expected in the first quarter of 2027, the same quarter as the first ASCEND monotherapy readout. At Thursday's close, shares were $12.48, against $12.58 at the prior close.

The next dated markers are the fourth-quarter 2026 APOLLO start and the first-quarter 2027 ASCEND readout.

### Sources

- [8-K Filing — CRESCENT BIOPHARMA, INC. (CBIO)](https://www.sec.gov/Archives/edgar/data/0001253689/000162828026066006/cbio-20261015.htm?ref=bullished.co) — SEC EDGAR