Evidence map›Paper›PMID 39976872›Full record

ArticleInvestigational new drugs2025

A phase I dose-escalation and expansion study of RMX1002, a selective E-type prostanoid receptor 4 antagonist, as monotherapy and in combination with anti-PD-1 antibody in advanced solid tumors.

Dan Liu, Jifang Gong, Jian Zhang, Yongqian Shu, Hao Wu, Tianshu Liu, Yanhua Xu, Lijia Zhang, Min Li, Xichun Hu and 1 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Investigational new drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Dan Liu *Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Center, Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, 100142, China.
Jifang Gong *Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Center, Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, 100142, China.
Jian Zhang *Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Yongqian ShuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210003, China.
Hao WuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210003, China.
Tianshu LiuCancer Center, Zhongshan Hospital, Fudan University, Shanghai, 200000, China.
Yanhua XuNingbo Newbay Pharmaceutical Technology Co., Ltd, Ningbo, 315000, China.
Lijia ZhangNingbo Newbay Pharmaceutical Technology Co., Ltd, Ningbo, 315000, China.
Min LiNingbo Newbay Pharmaceutical Technology Co., Ltd, Ningbo, 315000, China.
Xichun HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, China. xchu2009@hotmail.com.
Lin Shen, 399 Lingling Road, Xuhui District, Shanghai, 200000, China. shenlin@bjmu.edu.cn.

Funding

Ningbo Newbay Pharmaceutical Technology Co., Ltd n/a
6 · The paper itself

Abstract

RMX1002 (grapiprant) is a selective E-type prostanoid receptor 4 (EP4) antagonist and a promising candidate for cancer therapy, potentially enhancing anti-tumor immune responses. This study aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RMX1002 as monotherapy and in combination with anti-PD-1 antibody toripalimab for advanced solid tumors. This multicenter, phase I trial enrolled patients with histologically or cytologically confirmed advanced solid tumors. This study included three phases: Ia (dose-escalation of RMX1002 monotherapy from 200 to 650 mg BID), Ib (dose-escalation from 500 to 650 mg BID in combination with toripalimab), and Ic (dose-expansion of 500 mg BID with toripalimab). Safety, pharmacokinetics, pharmacodynamics, and efficacy were assessed. A total of 45 patients were enrolled (17 in phase Ia, 12 in phase Ib, and 16 in phase Ic). No dose-limiting toxicity was reported, and the MTD was not reached. Overall, 21 patients experienced RMX1002-related adverse events with CTCAE grade ≥ 3. Pharmacokinetics revealed rapid absorption of RMX1002 with the maximum concentration (C

Indexed as

Antineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsNeoplasmsReceptors, Prostaglandin E, EP4 SubtypeAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugFemaleHumansMaleMaximum Tolerated DoseMiddle AgedProgrammed Cell Death 1 ReceptorAntibodies, Monoclonal, HumanizedAntineoplastic AgentsPDCD1 protein, humanProgrammed Cell Death 1 ReceptorReceptors, Prostaglandin E, EP4 SubtypetoripalimabEP4GrapiprantImmunotherapyProstaglandin E2RMX1002Solid tumors

Identifiers

PMID39976872
PMCPMC12048420

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.