Kelun-Biotech readies first human data for its ITGB6-targeted ADC SKB105
The Phase 1/2 dose-escalation trial of CR-003 (SKB105), an integrin beta-6-directed antibody-drug conjugate, targets proof-of-concept data in Q1 2027, with no direct clinical precedent for the mechanism.
Executive Summary
- Kelun-Biotech is moving toward a first look at human data for an antibody-drug conjugate built on a tumor target that has no directly comparable clinical precedent, making the readout a test of an unproven mechanism rather than a competitive horse race.
- Because the trial is designed to find a tolerable dose and an early efficacy signal, the readout's value lies in whether toxicity stays manageable and tumor responses appear at doses that can be carried forward, not in a statistical win over a control arm.
- The sponsor has repeated the same guided data window across multiple disclosures without change, and the trial's move into active recruitment tracked that guidance, an operational signal that argues execution risk sits lower than typical for an early-stage oncology program.
- The absence of a same-target rival trial means this readout will function as the first data point on the biology itself, shaping how any partner or competitor thinks about integrin beta-6 as an oncology target going forward.
The trial
The study, registered as NCT07380386, is testing SKB105 for Injection in adults with advanced tumors who have failed or cannot tolerate standard therapy. It is a Phase 1/2, single-arm, industry-sponsored trial run in China, with an anticipated enrollment of 256 patients. The trial moved from Not yet recruiting to Recruiting on May 8, 2026, after starting on March 5, 2026. Its co-primary endpoints are the number of subjects experiencing dose-limiting toxicity (DLT) and objective response rate (ORR), with duration of response, overall survival and progression-free survival tracked as secondary measures. NCT07380386SKB105 for Injection in Advanced Solid TumorsNCT07380386
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the readout will test
SKB105, also known as CR-003, pairs an antibody against integrin beta-6 (ITGB6) with a topoisomerase-inhibitor payload, the same drug class architecture used across several antibody-drug conjugates now in oncology development. Kelun-Biotech has called it a next-generation topoisomerase-inhibitor ADC directed at a validated tumor target with best-in-class potential, both as a monotherapy and in combination with a partner's PD-1 x VEGF bispecific antibody. Because the co-primary endpoints are DLT and ORR, the Q1 2027 data will establish whether the dose-escalation portion identified a tolerable regimen and whether early tumor shrinkage appeared, the information a dose-finding study is built to produce. CrescentCrescent Biopharma Announces Transformational Partnership with Kelun-Biotech and $185 Million ...Dec 4, 2025
Timing track record
Kelun-Biotech and its partner have repeated the same Q1 2027 (January 1 to March 31) data-readout window across three separate disclosures dated December 4, 2025, February 26, 2026 and April 29, 2026. The trial's registered primary completion date is December 31, 2029, well beyond that window, which reflects that the Q1 2027 milestone is an interim proof-of-concept look inside a longer-running study rather than the trial's final readout. Enrollment guidance has held flat at 256 patients with no change recorded since the trial's registration, a routine signal for an early-phase program still in its first year of recruitment. Crescent+1Crescent Biopharma Announces Transformational Partnership with Kelun-Biotech and $185 Million ...Dec 4, 2025SKB105 for Injection in Advanced Solid TumorsNCT07380386
Competitive frame
No trial in the competitive field shares SKB105's integrin beta-6 target with a matching mechanism class, and the nearest comparators are modality-level precedents in tumors using different targets, including PD-L1, CTLA-4 and KRAS G12C-directed agents. A search across ITGB6-linked programs turned up one early-stage asset in the same target family, an antibody-drug conjugate from Seagen now in Phase 1 testing in advanced tumors, but it targets a different indication focus and is not eligible as a same-mechanism comparator. That isolation means the Q1 2027 data will read less as a competitive checkpoint and more as the first clinical evidence on whether integrin beta-6 is a workable ADC target in this tumor population.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.