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138 Phase 1 dose-escalation study of STRO-002, an anti-folate receptor alpha (FRα) antibody drug conjugate (ADC), in patients with advanced platinum-resistant/refractory epithelial ovarian cancer (OC)
  1. R Naumann1,
  2. F Braiteh2,
  3. J Diaz3,
  4. E Hamilton4,
  5. S Diab5,
  6. R Schilder6,
  7. J Moroney7,
  8. L Martin8,
  9. D Uyar9,
  10. D O’Malley10,
  11. R Penson11,
  12. C DiLea12,
  13. M Palumbo13,
  14. V DeAlmeida13,
  15. C Berman13,
  16. S Matheny13 and
  17. A Molina13
  1. 1Levine Cancer Institute, Carolinas Medical Center, USA
  2. 2Comprehensive Cancer Centers of Nevada, USA
  3. 3Miami Cancer Institute at Baptist Health, USA
  4. 4Sarah Cannon Research Institute, Tennessee Oncology PLLC, USA
  5. 5Rocky Mountain Cancer Center, USA
  6. 6Sidney Kimmel Cancer Center, Thomas Jefferson University, USA
  7. 7University of Chicago, USA
  8. 8University of Pennsylvania, Abramson Cancer Center, USA
  9. 9Medical College of Wisconsin, USA
  10. 10Ohio State University, Wexner Medical Center, USA
  11. 11Massachusetts General Hospital, USA
  12. 12Aclairo Pharmaceutical Development Group, USA
  13. 13Sutro Biopharma, USA


Introduction STRO-002 is a novel FRα-targeting ADC that delivers SC209, a potent tubulin-targeting hemiasterlin cytotoxin-warhead.

Methods All patients in the ongoing dose escalation study (NCT03748186) had platinum resistant/refractory OC without selection for FRα expression. STRO-002 is given IV on Day 1 of each 21-day cycle.

Results 38 patients have been dosed at 9 dose levels (0.5 to 6.4 mg/kg). Median number of cycles given is 3 (1–18). Median age is 61 (48–79). Median prior therapies - 5 (2–10). Clinically active doses (≥ 2.9 mg/kg) have been administered to 33 patients. 21/33 (64%) remain on treatment. Partial response was seen in 5 of 29 evaluable patients (17%) with 2 confirmed on second scan. 9 pts have confirmed SD for a clinical benefit rate of 48% (14/29). CA125 reduction of >50% was seen in 14/22 (64%) evaluable patients per GCIG. Clinical activity appears to be durable with 36% and 24% on study >16 and >24 weeks, respectively. 88% of AEs are grade 1 or 2. Grade 3–4 neutropenia, an expected and reversible effect of STRO-002 occurred in 15/38 (39%). DLTs reported – grade 3 neuropathy (6.0 mg/kg) and grade 3 bone pain (6.4 mg/kg).

Conclusions STRO-002 is a novel FRα-targeting ADC with a promising emerging safety and efficacy profile and preliminary clinical benefit/disease control rate of 48% in patients with relapsed/refractory OC treated at ≥ 2.9 mg/kg. No ocular toxicity signals have been observed, suggesting potential differentiation from other FRα-targeting investigational therapies. Expansion cohorts in less heavily pre-treated patients are planned for 4Q20.

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