670P - Preliminary efficacy and safety of tinengotinib (TT-00420) monotherapy in Chinese patients (pts) with advanced solid tumors: Results from a phase Ib/II study

Background

Tinengotinib is a spectrum-selective multi-kinase inhibitor that targets cell proliferation, angiogenesis, and immune-oncology pathways by inhibiting Aurora kinases A/B, Janus kinases and receptor tyrosine kinases (FGFRs and VEGFRs). Tinengotinib has shown promising clinical signal in solid tumors from several studies globally. Here we present the interim data from a phase Ib/II trial in China.

Methods

Pts with advanced/metastatic solid tumors were enrolled and treated with tinengotinib in 21-day cycle. Monotherapy and combination therapy with dose escalation (phase Ib) and dose expansion (phase II) were designed.

Results

As of 5-Mar-2023, thirty-three (33) pts have received tinengotinib monotherapy. Median age was 58.0 years (29-81), 66.7% were male, 81.8% had ECOG of 1, 87.9% had stage IV disease, 69.7% had ≥3 lines of prior therapies. No DLT was observed in phase Ib (3 pts in each group of 8, 10, 12 mg QD). 10 mg QD was selected as RP2D. Treatment-related AEs (TRAEs) were reported in 30 (90.9%) pts, Gr 3 in 14 (42.4%), Gr 4 in 1 (3.0%), and no Gr 5. The most common TRAEs (≥30%) included abnormal laboratory parameters (blood thyroid stimulating hormone increased, white blood cell count decreased, neutrophil count decreased, aspartate aminotransferase increased, alanine aminotransferase increased), palmar-plantar erythrodysaesthesia syndrome and anaemia. Among 22 efficacy-evaluable pts, the median Progression-free survival (PFS) have reached 6.70 (95% CI, 3.22-NA) months. For 19 pts with measurable target lesions, the overall response rate (ORR) and disease control rate (DCR) were 15.8% and 89.5%, respectively. For 4 CCA pts harboring FGFR2 alteration, ORR was 50%, DCR was 100%. One responder with prior treatment of erdafitinib achieved tumor reduction of 44%, the other with no prior FGFR inhibitor treatment achieved 69% reduction.

Conclusions

Tinengotinib monotherapy was well-tolerated in Chinese pts and 10 mg QD was selected as RP2D. Promising efficacy has been observed, especially in CCA with FGFR2 alteration. The ongoing study is to further evaluate the safety and efficacy of monotherapy and combination therapy.

Clinical trial identification

NCT05253053.

Editorial acknowledgement

Legal entity responsible for the study

TransThera Sciences (Nanjing), Inc.

Funding

TransThera Sciences (Nanjing), Inc.

Disclosure

J. Fan: Financial Interests, Personal, Officer, I am Chief Medical Officer, full time employee at TransThera Sciences, Inc.: TransThera Sciences, Inc.; Financial Interests, Personal, Stocks/Shares, I owned AstraZeneca's stocks: AstraZeneca; Non-Financial Interests, Member: ASCO, ESMO, AACR. L. Shen: Financial Interests, Personal, Other, Consulting fees: Mingji biopharmaceutical, Haichuang pharmaceutical, Herbour biomed; Financial Interests, Personal, Advisory Board: MSD, Merck, BMS, BI, Sanofi, Roche, Servier, AZ; Financial Interests, Institutional, Funding: Beijing Xiantong Biomedical Technology, Qilu Pharmaceutical, ZaiLab Pharmaceutical (Shanghai), Alphamab Oncology, Yaojie Ankang (Nanjing) Technology Co., Ltd., BeiGene, Ltd., Qiyu Biotechnology (Shanghai) Co., Ltd., BriSTAR Immunotech; Financial Interests, Institutional, Local PI: Merck Healthcare KGaA, Roche; Financial Interests, Institutional, Trial Chair: Rongchang Pharmaceutical, Innovent, BeiGene, Ltd., Qilu Pharmaceutical, NovaRock Biotherapeutics Limited. All other authors have declared no conflicts of interest.