GROKS Take.
Estimating how long it will take to get readouts from Race Oncology’s Phase 1 trial for RC220 involves some educated guesswork, since exact timelines depend on variables like enrolment speed, patient response, and data analysis, which aren’t fully public yet.
But I can piece together a reasonable timeline based on what’s known about the trial’s structure, standard Phase 1 durations, and Race’s own updates as of April 6, 2025.The trial kicked off with its first Australian site, Southside Cancer Care Centre in Miranda, NSW, opening for patient enrollment on April 3, 2025, per Race’s ASX announcement and X posts from that week. It’s an open-label, multi-center study with two stages: Stage 1 (dose escalation) aims to enroll up to 33 patients to find the maximum tolerated combined dose (MTCD) of RC220 and doxorubicin, and Stage 2 (expansion) will add more patients—up to 53 total across both stages—to confirm safety and explore early efficacy signals.
The trial spans sites in Australia, Hong Kong, and South Korea, with most Australian sites expected to activate in Q1-Q2 2025 and Hong Kong/South Korea in Q3 2025, according to Proactive Investors (March 14, 2025).Phase 1 trials typically take 6-18 months from first patient enrollment to initial readouts, depending on how fast they recruit and how long dosing cycles last.
Race’s trial uses a Bayesian adaptive design, which can speed things up by adjusting doses on the fly rather than waiting for fixed cohorts to finish. Each patient in Stage 1 gets RC220 alone on Day 1, then combined with doxorubicin in 21-day cycles. If they aim for, say, 3-6 cycles per patient to assess safety (common in oncology Phase 1s), that’s 2-4 months per cohort, plus time between cohorts for analysis. Stage 1 might wrap in 6-12 months if enrollment clips along—say, 3-5 patients per month across multiple sites once they’re all active.Enrollment pace is the big variable. The first site’s open now, but others are still ramping up.
Race projected first patient treatment in Q1 2025 back in January (Proactive Investors, January 31, 2025), and they hit that with the April start. If they get all 33 Stage 1 patients enrolled by late 2025—optimistic but possible with 10 sites—they could finish dosing by mid-2026. Stage 2 would follow, adding a few more months.
Data cleanup and analysis might take another 2-3 months. So, a rough guess: initial Stage 1 readouts (safety and MTCD) could land between April and October 2026, with full trial data (including Stage 2) stretching into early 2027.That said, delays are common. If sites activate slower (Hong Kong/South Korea lag to Q3), or if they hit dose-limiting toxicities needing extra cohorts, add 3-6 months.
Conversely, if preclinical promise (like RC220’s synergy with doxorubicin in 85% of cancer cell lines) holds and enrollment flies, we might see something by early 2026. Race’s CEO, Daniel Tillett, has emphasised efficiency, so they’re motivated to move fast.My best guess: expect preliminary readouts around Q2-Q3 2026—about 15-18 months from now—assuming steady progress.
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