Thanks for confirming. I’ll review the thread you linked and extract the top 10 key points specifically from @RaceOncology’s responses that relate to RC220.
I’ll summarize these points clearly for you once the analysis is complete.

Key Insights from RaceOncology on RC220 Phase 1 Trial (HotCopper Thread)

In a HotCopper forum discussion about the first patient dosed safely with RC220 in a Phase 1 trial, user @RaceOncology (an official company representative) provided valuable insights. Below are the top 10 key points from RaceOncology’s comments regarding RC220:

1. Long Road to First Dosing: Reaching the first patient dosing of RC220 was a significant milestone that took considerable time and effort. “It has been quite the journey getting to this point…” RaceOncology noted, underscoring the importance of this event.

2. Bayesian Dose-Escalation Design: The Phase 1 trial uses a Bayesian dose-escalation design, which allows for flexible and data-driven dosing adjustments. As patients are treated, emerging safety data will guide whether to escalate to higher doses more quickly (rather than a fixed 3+3 scheme). This design is intended to speed up finding the optimal dose while ensuring safety.

3. Planned Doxorubicin Combination (Phase 1b): The trial is split into two stages. In the upcoming Phase 1b, RC220 will be given in combination with doxorubicin (a standard chemotherapy) to determine a safe combined dosage. This means once RC220’s safe dose is established alone, they will assess adding it to doxorubicin to see how well patients tolerate the two drugs together.

4. Rationale for Using Doxorubicin: RaceOncology explained that doxorubicin was chosen for the combo stage because it’s a highly effective cancer drug used in most solid tumors. By pairing RC220 with this widely-used chemo, the trial can evaluate RC220 in a relevant and potent therapy context. In other words, doxorubicin’s broad efficacy makes it an ideal partner drug to test RC220’s performance and safety alongside.

5. “Clinically Meaningful” Starting Dose: The starting dose of RC220 in this first-in-human trial is not just a trivial amount, but a dose expected to have real biological relevance. RaceOncology emphasized that the initial dose is “clinically meaningful”, while of course being within safe limits. This suggests they did not start at an extremely low dose – they leveraged preclinical data to choose a dose that could provide informative results even in the first patients.

6. Strong Safety Profile from Preclinical Studies: Previous studies and data gave the team confidence in RC220’s safety. RaceOncology pointed out that non-clinical studies demonstrated RC220’s favorable safety profile, supporting its advancement into human trials. In short, lab and animal testing indicated RC220 (bisantrene) is well-tolerated, which bodes well for its behavior in patients.

7. 21-Day Cycle for Safety Evaluation: Patients are dosed on a 21-day cycle, and roughly one cycle is needed to evaluate safety before moving to the next step. RaceOncology indicated that about 21 days after the first patient’s dose would be the timing for dosing the first patient at the next trial site. This implies that one full treatment cycle is observed for any dose-limiting toxicities; if none are seen, they can escalate the dose or open additional sites for new patients. It highlights the cautious but efficient progression – one cycle per dose level to confirm safety.

8. Second Site Activated to Accelerate Enrollment: The trial is multi-site. In fact, a second clinical site was ready to dose its first patient roughly three weeks after the first site’s initial dose. This staggered start (about one 21-day cycle apart) shows that Race Oncology is quickly expanding the trial to more hospitals. By running the study at multiple sites in parallel (including additional Australian hospitals and planned sites in Hong Kong and South Korea), they aim to speed up patient recruitment and dose escalation.

9. Focus on Safety, Tolerability, and PK (Not Efficacy Yet): RaceOncology reiterated that the primary goal of this Phase 1 trial is to establish RC220’s safety, tolerability, and pharmacokinetics in humans. It’s an early-stage trial, so it is not designed to measure how effective RC220 is against tumors at this point. Any anti-tumor effects observed would be anecdotal; the real endpoints are finding a safe dose (and safe RC220+doxorubicin combination dose) and understanding how the drug behaves in the body. These data will set the stage for later trials focused on efficacy.

10. Up to ~33 Patients in Dose Escalation: The dose-escalation phase (Phase 1a) can enroll up to 33 patients to find the maximum tolerated dose of RC220. However, thanks to the adaptive Bayesian design, it may not require all 33 to reach the target dose – the exact number will depend on when safety signals dictate a stopping point. This flexibility means the trial will only enroll as many patients as needed to confidently identify a safe and optimal dose range for RC220 moving forward.

Each of these points was drawn from the RaceOncology user’s comments on HotCopper, providing investors and followers with deeper context about the RC220 Phase 1 trial beyond the basic press announcement. Taken together, the comments convey optimism about RC220’s progress, a careful plan to ensure safety at each step, and a clear strategy to accelerate development of this promising therapy.

Sources:

• RaceOncology user comments on HotCopper thread “Ann: First Patient Dosed Safely in RC220 Phase 1 Trial”.