Not yet recruitingNCT07806500Updated Sep 8, 2026

Phase Ib Study of Oral R01 Monotherapy in Advanced Solid Tumors

A Phase 1 interventional study of R01 in Squamous Cell Lung Cancer, Gastric Cancer and Esophageal Cancer, sponsored by Beijing Anjianxi Bio-Medical Technology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Beijing Anjianxi Bio-Medical Technology Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study summary

This is a Phase I（Ib）, open-label, single-arm clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of R01 administered orally as monotherapy twice daily (BID) in patients with advanced solid tumors, including squamous cell lung cancer, gastric cancer , and esophageal cancer.

Patients with advanced squamous cell lung cancer, gastric cancer , and esophageal cancer will be enrolled. All subjects will receive oral R01 monotherapy and will undergo physical examinations, laboratory tests, radiographic tumor response assessments, biological sample collection, and safety follow-ups as specified in the protocol.

The study comprises two consecutive sub-stages: a dose-bridging escalation stage (i.e., a dose escalation stage designed to bridge from the highest dose evaluated in Phase Ia) and a dose expansion stage. The dose escalation follows a classic '3+3' design at three dose levels (240, 320, and 400 mg BID). The 400 mg dose may be initiated after the Safety Review Committee (SRC) review based on safety and PK data. The primary objectives of this stage are to characterize dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and establish the recommended Phase II dose (RP2D).

The dose expansion stage will be conducted at the RP2D in selected indication cohorts, with a planned enrollment of at least 6 subjects per cohort (including subjects with the corresponding indications enrolled at the same dose level during the dose escalation stage), to further evaluate the safety, tolerability, PK characteristics, and preliminary antitumor efficacy at this dose level.

With respect to study endpoints: during the dose escalation stage, the primary endpoints are the incidence of DLTs, the MTD, and/or the determination of the expansion dose (RP2D); secondary endpoints include PK parameters of R01 and its metabolites, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). During the dose expansion stage, the primary endpoints are ORR and the incidence and severity of treatment-related adverse events (TRAEs); secondary endpoints include duration of response (DOR), time to response (TTR), DCR, PFS, OS, and steady-state PK parameters.

Conditions studied

Squamous Cell Lung Cancer
Gastric Cancer
Esophageal Cancer

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Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment in this study:
1. Age: 18 to 75 years (inclusive), of any sex.
2. Patients with unresectable squamous cell lung cancer, gastric cancer, or esophageal cancer confirmed by histology or cytology, specifically including those in whom existing standard therapy has failed (≥1 line) or who cannot tolerate standard therapy, or who have evidence of locoregional recurrence or metastasis and are not suitable for curative-intent surgical resection or radiotherapy; the investigator comprehensively assesses that the clinical trial participant is not suitable to receive standard treatment.
3. Tumor type: advanced squamous cell lung cancer, gastric cancer (including signet-ring cell gastric cancer), and esophageal cancer.
4. At screening, presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions previously treated with radiotherapy or other locoregional therapy are considered measurable only if progressive disease (PD) at the treated site has been clearly documented after completion of the treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Expected survival of at least 12 weeks.
7. Essentially normal function of major organs, with laboratory values at screening meeting the following criteria:
1. . ANC ≥1500/mm³ (1.5×10⁹/L);
2. . PLT ≥75,000/mm³ (75×10⁹/L);
3. . Hb ≥9 g/dL (90 g/L) (most recent test during the screening period, and within 7 days before the first dose);
4. . Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≤2.5× the upper limit of normal (ULN); if liver metastases are present, both ALT and AST ≤5.0× ULN;
5. . Total bilirubin (TBIL) ≤1.5× ULN;
6. . Serum creatinine (SCr) ≤1.5× ULN or estimated creatinine clearance (CrCl) ≥50 mL/min (according to the Cockcroft-Gault formula);
7. . Albumin (ALB) ≥28 g/L;
8. . Serum potassium ≥3.5 mmol/L and ≤5.5 mmol/L.
8. Prior to the first dose, all acute toxicities from prior anticancer therapy or surgery must have resolved to baseline severity or to Grade ≤1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0, with the exception of alopecia, skin pigmentation changes, and toxicities judged by the investigator to be clinically insignificant; peripheral neuropathy of Grade ≤2 is permitted.
9. Voluntarily participate in the clinical trial and sign the informed consent form (ICF).

Exclusion criteria

Exclusion Criteria:

Patients meeting any of the following criteria will not be enrolled in this study:
1. Patients with advanced disease at risk of life-threatening complications in the short term (patients with visceral crisis).
2. Known or symptomatic active CNS metastases, manifesting as clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth.
3. Major surgery, chemotherapy, radiotherapy, any investigational drug, or other anti-cancer therapy within 4 weeks before the first dose.
4. Patients who have not been withdrawn from another clinical trial within 4 weeks before study entry, or who are currently participating in another clinical trial involving an investigational drug or device.
5. Known history of allergy or suspected allergic symptoms to any component of the R01 formulation.
6. Use, within 14 days or 5 drug half-lives before the first dose (whichever is shorter), of: drugs known to be strong inhibitors/inducers of CYP3A4 or CYP2D6; drugs known to significantly prolong the QT interval.
7. At screening, a mean corrected QT interval (QTcF) >480 msec based on the average of 3 ECG assessments at rest (repeat testing and averaging of 3 values is required only if the first ECG indicates QTcF >480 msec); history of long QT syndrome or a confirmed family history of long QT syndrome; history of clinically significant ventricular arrhythmia, or current use of antiarrhythmic drugs, or an implanted defibrillation device used to treat ventricular arrhythmia.
8. Uncontrolled electrolyte disturbances that may affect the action of drugs that prolong the QTcF interval (e.g., hypocalcemia below the lower limit of normal (LLN), hypokalemia \<3.5 mmol/L, hyperkalemia >5.5 mmol/L).
9. Concurrent severe/unstable angina pectoris; persistent arrhythmia of NCI CTCAE version 6.0 grade ≥2; atrial fibrillation of any grade; symptomatic congestive heart failure; cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); myocardial infarction within 6 months, or prior coronary/peripheral artery bypass surgery.
10. Clinically significant active infections, including hepatitis B, hepatitis C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases, syphilis, active tuberculosis infection, and other diseases posing a risk of transmission, as well as uncontrolled systemic bacterial/fungal/other viral infections. Active hepatitis B is defined as: positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg), with hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥2000 IU/mL (equivalent to 10⁴ copies/mL); active hepatitis C is defined as a positive HCV RNA test result; active syphilis is defined as a positive rapid plasma reagin (RPR) or Venereal Disease Research Laboratory (VDRL) test or the presence of clinical symptoms; active tuberculosis infection is defined as a positive T-SPOT.TB test or positive tuberculin skin test with purified protein derivative (PPD).
11. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities, that may increase the risk of participating in the study or the risk associated with administration of the investigational drug, or that may interfere with the study results, as well as any other condition that the investigator considers to make the patient unsuitable for participation in this study.
12. Diabetic patients whose blood glucose is not effectively controlled (repeated fasting blood glucose [FBG] >7.0 mmol/L).
13. Persistently elevated corrected serum calcium levels on the 2 most recent independent tests (interval ≥24 h), ≥2.7 mmol/L (10.8 mg/dL) or exceeding the upper limit of the laboratory reference range.
14. Female clinical trial participants of childbearing potential with a positive pregnancy test at screening, or who do not agree to use highly effective contraception during the study and for 6 months after the last dose; male clinical trial participants who do not agree to use contraception during the study and for 6 months after the last dose, or who do not agree to refrain from donating sperm.
15. Recent or active suicidal ideation or behavior.
16. Conditions affecting the intake or absorption of oral drugs, including but not limited to: inability to swallow oral medications; persistent nausea or vomiting of ≥ CTCAE grade 2; severe aversion to fatty food or active malabsorption syndrome; Crohn's disease, ulcerative colitis, or short bowel syndrome in an acute episode.
17. History of major small intestinal or colonic surgery that may significantly affect the absorption of oral drugs.
18. Use of erythropoietin (EPO) or erythropoiesis-stimulating agents (ESA) within 28 days before the first dose.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (estimated)

Study arms

Experimental
Experimental: R01 Oral Monotherapy
This is a single-arm, open-label study consisting of a dose escalation phase and a dose expansion phase. The investigational product R01 is an oral formulation for the treatment of patients with advanced solid tumors.The dose escalation phase will evaluate three prespecified dose levels (240 mg BID, 320 mg BID, and 400 mg BID). Participants will be enrolled sequentially to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion. In the dose expansion phase, participants will uniformly receive the expansion dose determined during the dose escalation phase to further evaluate safety and preliminary efficacy.All participants will receive oral R01 twice daily, with each treatment cycle consisting of 21 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or other discontinuation criteria specified in the protocol.
Drug: R01

Interventions

DrugR01
The study consists of two parts: (1) Dose Escalation Phase: Three prespecified escalating dose levels will be evaluated: 240 mg BID, 320 mg BID, and 400 mg BID. (2) Dose Expansion Phase: Subjects will receive the expansion dose determined in the dose escalation phase. All subjects will receive R01 orally, twice daily, with each treatment cycle consisting of 21 days. Treatment will continue until the discontinuation criteria specified in the study protocol are met.

What researchers measure

Primary outcomes

Number of Participants with Dose-Limiting Toxicities (DLTs)
Dose-limiting toxicity (DLT) is defined as a toxicity occurring during the observation window at any dose level, judged by the investigator to be related to R01, and meeting any of the following criteria: Hematologic toxicities: Grade 4 hematologic toxicity; Grade 4 neutropenia persisting for \>7 days despite G-CSF treatment; Grade 4 anemia not recovering to ≤Grade 2 within 14 days despite transfusion support; Grade 4 thrombocytopenia regardless of bleeding; Febrile neutropenia ; Grade 3 thrombocytopenia with clinically significant bleeding. Non-hematologic toxicities: Grade ≥3 non-hematologic toxicity; QTcF \>500 ms or increase of \>60 ms from baseline confirmed by repeat ECG; Grade ≥3 hypoxemia or Grade ≥3 dyspnea; Actual dosing in Cycle 1 \<75% of planned dose or dosing delay \>14 days due to study drug-related toxicity. DLTs will be assessed according to CTCAE v6.0 during the DLT observation window.
Time frame: Cycle 1 (21 days)
Determination of Maximum Tolerated Dose (MTD) and/or Expansion Dose
The maximum tolerated dose (MTD) is defined as the highest dose level at which ≤1 of 6 participants experiences a dose-limiting toxicity (DLT) during the DLT observation window. DLTs will be assessed according to CTCAE v6.0. The MTD will be determined using a standard 3+3 dose escalation design. The expansion dose will be selected based on the MTD, pharmacokinetic exposure, safety, tolerability, and preliminary efficacy observed during the dose escalation phase, and will not exceed the MTD.
Time frame: From the beginning of first patient in (FPl) to the end of dose escalation phase up to approximately 9 months
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a confirmed best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1. CR is defined as the disappearance of all target lesions and any pathological lymph nodes (short axis \<10 mm). PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. All responses must be confirmed by a repeat assessment performed no less than 4 weeks after the initial response is first documented. ORR will be reported for each dose cohort and for the overall study population. The 95% confidence interval (CI) for ORR will be calculated using the Clopper-Pearson exact method.
Time frame: From the beginning of first patient in (FPl) to the end of dose expansion phase up to approximately 4 months
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Treatment-emergent adverse events (TEAEs) are defined as adverse events that start or worsen in severity after the first dose of study drug (R01) through 30 days after the last dose of study drug, or until initiation of another antineoplastic therapy, whichever occurs first. Treatment-related adverse events (TRAEs) are defined as TEAEs for which the investigator assesses a causal relationship to the study drug as possibly, probably, or definitely related. The incidence and severity of TEAEs and TRAEs will be summarized by dose cohort and for the overall safety population. Severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Time frame: From first dose to 30 days after last dose

Secondary outcomes

Pharmacokinetic (PK) parameters of R01 and its metabolites
Single-dose PK parameters of R01 and its metabolites include maximum plasma concentration (Cmax), time to maximum concentration (Tmax), area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC₀-ₜ), area under the plasma concentration-time curve from time zero to infinity (AUC₀-∞), and terminal elimination half-life (t½). Steady-state PK parameters include area under the plasma concentration-time curve over one dosing interval (AUCτ), maximum plasma concentration at steady state (Cmax,ss), trough plasma concentration at steady state (Ctrough,ss), and accumulation ratio (Rac).
Time frame: Cycle 0 (single-dose PK, 3 days); Cycle 1 (steady-state PK, 21 days)
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a confirmed best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1. CR is defined as the disappearance of all target lesions and any pathological lymph nodes (short axis \<10 mm). PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. All responses must be confirmed by a repeat assessment performed no less than 4 weeks after the initial response is first documented. ORR will be reported for each dose cohort and for the overall study population. The 95% confidence interval (CI) for ORR will be calculated using the Clopper-Pearson exact method.
Time frame: From the beginning of first patient in (FPl) to the end of dose escalation phase up to approximately 9 months
Disease control rate (DCR)
DCR is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PRI nor sufficient increase to qualify for progressive disease (PD), maintained for at least \[X\] weeks.
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 13 months
Progression-free survival (PFS)
PFS is defined as the time from the date of first dose to the date of first documented disease progression (PD) per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first. Participants who have not progressed or died at the time of analysis will be censored at the date of their last evaluable tumor assessment.
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 13 months
Overall survival (OS)
OS is defined as the time from the date of first dose to the date of death due to any cause.
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 13 months
Duration of response (DOR)
DOR is defined, for participants who achieve a best overall response of complete response (CR) or partial response (PR), as the time from the date of first documented response (CR or PR) to the date of first documented disease progression (PD) per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first. Responders who have not progressed or died at the time of analysis will be censored at the date of their last evaluable tumor assessment.
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 4 months
Time to response (TTR)
TTR is defined, for participants who achieve a best overall response of complete response (CR) or partial response (PR), as the time from the date of first dose to the date of first documented response (CR or PR), as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 4 months

Other outcomes

Change from Baseline in Functional Pharmacodynamic Parameters (Hemoglobin, Red Blood Cell Count, and Reticulocyte Count)
Functional pharmacodynamic (PD) parameters, including hemoglobin (Hb), red blood cell count (RBC), and reticulocyte count (Ret), will be measured at scheduled time points throughout the study. The change from baseline in each parameter will be calculated and summarized by dose cohort and for the overall study population. Baseline is defined as the last available measurement prior to the first dose of study drug (R01). Descriptive statistics will be provided for absolute values and change from baseline at each scheduled assessment time point. These parameters will be explored as potential indicators of pharmacodynamic activity of R01.
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 13 months
Exploratory Biomarker Analysis and Association with Drug Exposure and Clinical Efficacy
At baseline, metastatic lymph node samples may be collected from participants eligible for biopsy to evaluate the effect of R01 on tumor tissue-specific PD biomarkers.Baseline is defined as the tumor tissue sample collected prior to the first dose of R01.
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 13 months

Study locations

1 site

Aerospace Central Hospital, Beijing, China, 100049
Beijing, Beijing Municipality 100049, China
- Siyi Zhang · Contact · siyi.zhang@zysmo.com · 86+18742546937
- Yuankai Shi, MD · Principal investigator
- Zhanggui Wang, MD · Sub investigator

References and documents

Publications

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Kao TW, Bai GH, Wang TL, Shih IM, Chuang CM, Lo CL, Tsai MC, Chiu LY, Lin CC, Shen YA. Novel cancer treatment paradigm targeting hypoxia-induced factor in conjunction with current therapies to overcome resistance. J Exp Clin Cancer Res. 2023 Jul 18;42(1):171. doi: 10.1186/s13046-023-02724-y. PubMed 37460927 ↗
Semenza GL. Development of small molecule inhibitors of hypoxia-inducible factors for cancer therapy. Pharmacol Rev. 2025 Sep;77(5):100075. doi: 10.1016/j.pharmr.2025.100075. Epub 2025 Jun 26. PubMed 40743978 ↗
Albadari N, Deng S, Li W. The transcriptional factors HIF-1 and HIF-2 and their novel inhibitors in cancer therapy. Expert Opin Drug Discov. 2019 Jul;14(7):667-682. doi: 10.1080/17460441.2019.1613370. Epub 2019 May 9. PubMed 31070059 ↗
Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30. PubMed 31582355 ↗
Kojima T, Shah MA, Muro K, Francois E, Adenis A, Hsu CH, Doi T, Moriwaki T, Kim SB, Lee SH, Bennouna J, Kato K, Shen L, Enzinger P, Qin SK, Ferreira P, Chen J, Girotto G, de la Fouchardiere C, Senellart H, Al-Rajabi R, Lordick F, Wang R, Suryawanshi S, Bhagia P, Kang SP, Metges JP; KEYNOTE-181 Investigators. Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer. J Clin Oncol. 2020 Dec 10;38(35):4138-4148. doi: 10.1200/JCO.20.01888. Epub 2020 Oct 7. PubMed 33026938 ↗
Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Alsina M, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Hosokawa A, Yalcin S, Fujitani K, Beretta GD, Cutsem EV, Winkler RE, Makris L, Ilson DH, Tabernero J. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1437-1448. doi: 10.1016/S1470-2045(18)30739-3. Epub 2018 Oct 21. PubMed 30355453 ↗
Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F, Hammershaimb L. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol. 2000 Jun;18(12):2354-62. doi: 10.1200/JCO.2000.18.12.2354. PubMed 10856094 ↗
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Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared with other researchers, because the study data include proprietary and confidential information of the sponsor, and to protect participant privacy.

Registry details

Key details

Study ID: NCT07806500
Lead sponsor: Beijing Anjianxi Bio-Medical Technology Co., Ltd.
Responsible party: Sponsor
First posted: Sep 8, 2026
Start date: Sep 2026 (estimated)
Primary completion: Sep 2027 (estimated)
Completion: Sep 2027 (estimated)
Last update: Sep 8, 2026

Study contacts

Haiyong Wang, PhD

Contact

wanghy@ajxmed.com

86+18911251079

Yuankai Shi, MD

principal investigator · Aerospace Center Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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