A Phase 1 Dose-Escalation Study of PF-06671008, a Bispecific T-Cell-Engaging Therapy Targeting P-Cadherin in Patients With Advanced Solid Tumors.

P-cadherin is a cell-cell adhesion molecule that is overexpressed in several solid tumors. PF-06671008 is a T-cell-redirecting bispecific antibody that engages both P-cadherin on tumors and CD3ϵ on T cells and induces antitumor activity in preclinical models. We conducted a phase 1, open-label, first-in-human, dose-escalation study to characterize the safety and tolerability of PF-06671008, towards determining the recommended phase 2 dose. Adult patients with treatment-refractory solid tumors received PF-06671008 (1.5-400 ng/kg) as a weekly intravenous (IV) infusion on a 21-day/3-week cycle. Parallel cohorts evaluated dosing URL: https://clinicaltrials.gov/ct2/show/NCT02659631, ClinicalTrials.gov Identifier: NCT02659631.

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Copyright © 2022 Harding, Garrido-Laguna, Chen, Basu, Dowlati, Forgie, Hooper, Kamperschroer, Max, Moreau, Shannon, Wong and Hong.

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JH, grant support from Bristol Myers Squibb and consultancy fees from Bristol Myers Squibb, Merck, Eisai, Exelexis, Eli Lilly, QED, Adaptimmune, Imvax, and Cytomx. IG-L, consultancy fees from Eisai and Array, research support (institution) from Amgen, Bridgebio, Jacobio, Tolero, Trishula, Bayer, Seattle Genetics, Lilly, Incyte, GSK, Pfizer, and Redhill. AD, fees for advisory boards from AstraZeneca, Seattle Genetics, Ipsen, Bayer, Bristol Myers Squibb, Merck and G1 Therapeutics. DH, research/grant funding (institution) from AbbVie, Adaptimmune, Adlai-Nortye, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi-Sankyo, Deciphera, Eisai, Erasca, Fate Therapeutics, Genentech, Genmab, Ignyta, Infinity, Kite, Kyowa Kirin, Lilly, LOXO, Merck, Medimmune, Mirati, Mologen, Navier, NCI-CTEP, Novartis, Numab, Pfizer, Pyramid Bio, SeaGen, Takeda, Teckro, Turning Point Therapeutics, Verstatem, and VM Oncology; travel/accommodation/expenses from Bayer, Genmab, AACR, ASCO, SITC, and Telperian; consulting/speaker/advisory role for Adaptimmune, Alpha Insights, Acuta, Alkermes, Amgen, Aumbiosciences, Axiom, Baxter, Bayer, Boxer Capital, BridgeBio, COR2ed, COG, Ecor1, Genentech, Gilead, GLG, Group H, Guidepoint, HCW Precision, Immunogen, Infinity, Janssen, Liberium, Medscape, Numab, Oncologia Brasil, Pfizer, Pharma Intelligence, POET Congress, Prime Oncology, Seattle Genetics, ST Cube, Takeda, Tavistock, Trieza Therapeutics, Turning Point, WebMD, and Ziopharm; other ownership interest in Molecular Match (Advisor), OncoResponse (Founder), Telperian (Advisor). AM and CB, employed by Pfizer and hold stock in Pfizer. GW, AH, AF, SM, CK, XC, and MS, previously employed by Pfizer and hold stock in Pfizer.