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Testing SAF-189s for advanced lung cancer patients

A Phase I/II, Multi-center Clinical Study: Dose-finding Phase I Study of Foritinib Succinate in Advanced ALK-positive NSCLC Patients and Phase II Study of Foritinib Succinate in ALK or ROS1-positive NSCLC Patients

Phase1; Phase2 Interventional Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · NCT04237805

This study is testing a new treatment called SAF-189s to see if it can help people with advanced lung cancer who haven't had success with other therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years and up
SexAll
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Industry-sponsored
Drugs / interventionscrizotinib, chemotherapy, radiation, prednisone, foritinib, remitinib
Locations41 sites (Bengbu, Anhui and 40 other locations)
Trial IDNCT04237805 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, single-arm, open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of SAF-189s in patients with advanced ALK-positive non-small cell lung cancer (NSCLC). It consists of two phases: the first phase focuses on dose escalation to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D), while the second phase assesses the efficacy and tumor activity of the treatment. Patients enrolled in the study must have progressed on standard therapies and meet specific eligibility criteria related to their cancer type and treatment history.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with advanced ALK-positive or ROS1-positive NSCLC who have progressed on standard therapies.

Not a fit: Patients with early-stage lung cancer or those who have not received prior treatment for their advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced ALK-positive NSCLC who have limited treatment options.

How similar studies have performed: Other studies have shown promise with similar approaches targeting ALK and ROS1 mutations in lung cancer, indicating a potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1) Have a full understanding of this study and voluntarily sign an informed consent form (ICF) 2）Phase I dose escalation : the patients with advanced ALK-positive malignant solid tumor who have progressed on standard therapies; Phase I study: histologically or cytologically confirmed, locally advanced ALK-positive and/or metastatic stage IIIB/IV NSCLC who have progressed on standard therapy; Phase II Study Part I: Patients with histologically and/or cytologically confirmed ALK or ROS1 positive locally-advanced and/or metastatic stage IIIb \~IV NSCLC;Patients who had not previously received or had received only one ALK/ROS1 inhibitor for disease progression or intolerance, and who had no more than 3 previous treatment lines overall Phase II Study Part Ⅱ: cohort1：ROS1-positive locally advanced and/or metastatic stage IIIB\~IV NSCLC patients diagnosed histologically and/or cytologically, with no prior systemic therapy or only one line of non-ROS1-inhibitor treatment cohort 2: patients with histologically and/or cytologically confirmed ROS1-positive locally advanced and/or metastatic stage IIIb \~IV NSCLC who had previously only received crizotinib as a ROS1 inhibitor for disease progression or intolerance and had no more than 3 overall previous treatment lines； 3) At least one measurable lesion per RECIST1.1; Note: a lesion previously treated by radiotherapy is not considered as a target lesion, unless confirmed progression is documented after radiotherapy.

4) ECOG performance score ≤ 2; 5) Male or female patients ≥ 18 and ≤ 75 years old in Phase I ；Male or female patients ≥ 18 in Phase II 6) Life expectancy ≥ 12 weeks; 7) Patient with appropriate organ function as documented by:

1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
2. Hemoglobin ≥ 90 g/L;
3. Platelets (PLT) ≥ 100 × 109/L
4. Serum total bilirubin ≤ 1.5 × ULN (if the patient has Gilbert's syndrome, ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN);
5. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patient with liver metastases);
6. Creatinine clearance (CrCL) ≥ 50 mL/min (calculated by Cockcroft-Gault equation)
7. Fasting blood glucose ≤ 200 mg/dL (≤ 11.1 mmol/L) 8) Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 per NCI-CTCAE (Version 4.03), exception of alopecia; 9）Within 21 days prior to enrolment, women of reproductive age had to confirm a negative serological pregnancy test and agree to use an effective contraceptive method for all study drug use and for 28 days after the last dose.For the purposes of this protocol, women of childbearing age are defined as sexually mature women who: 1) have not undergone hysterectomy or bilateral oophorectomy, or 2) have natural menopause that has not lasted continuously for 24 months (amenorrhea after cancer treatment does not exclude fertility) (i.e., have had menstruation at any time during the previous consecutive 24 months);

Exclusion Criteria:

1. Has had prior chemotherapy, anti-cancer treatment with biological drugs, or other investigational agents within 28 days or received TKI or targeted therapies within 14 days prior to enrollment;
2. Received radiotherapy within 21 days prior to the 1st dose or continuance of toxicities due to prior radiotherapy that do not recover to Grade 0 or 1;
3. Patients who received major surgery within 3 weeks before enrollment or have not adequately recovered from prior surgery;
4. Patients with central nervous system (CNS) metastases requiring

   1. Clinical local intervention such as surgical excision, radiotherapy or other therapies
   2. Phase I dose escalation: patients requiring systemic treatment with corticosteroids (\>10 mg/day prednisone or equivalent) are not eligible for dose escalation study (not applicable to patients participating Phase I cohort expansion or Phase II).
5. Diabetics without stable control and with insulin therapy (patients with fasting blood glucose below 7mmol/L, who are receiving stable hypoglycemic drug regimen, and whose blood glucose control is stable as evaluated by specialist doctors are allowed to be enrolled); 6）Difficulty in swallowing or having an active digestive disorder or having undergone major gastrointestinal surgery may significantly affect the administration or absorption of SAF189s (e.g. ulcerative lesions, uncontrollable nausea, vomiting, diarrhoea, malabsorption syndrome, and enteroctomies) 7）Patients who are taking the following medicines:

   1. Repaglinide (cytochrome \[CYP\]2C8) and drugs metabolized via CYP3A4 enzyme within 1 week before enrollment;
   2. Medicines which are known to cause QT prolongation or torsade de pointes;
   3. Coumarin anticoagulants within 1 week before enrollment (low molecular weight heparin is permitted);
   4. Illegal drugs;

8) Has a history of acute pancreatitis within 1 year before enrollment, or past history of chronic pancreatitis; 9) Patients have positive laboratory test for anti-HCV, or are diagnosed with human immunodeficiency virus (HIV) infection, or who refuse to receive HIV screen test; 10) Patients have other malignant tumor history or with other malignant tumors simultaneously; 11) Impairment of cardiac function or clinically significant heart disease, including New York College of Cardiology (NYHA) grade ≥ 3 congestive heart failure, arrhythmias, conduction abnormalities requiring treatment, cardiomyopathy, or uncontrolled hypertension； 12) Corrected QT interval using Fridericia formula \> 450 msec for male patients and \> 470 msec for female patients; 13) Patients have uncured interstitial lung disease history or non-infectious pneumonitis prior to enrollment, except for those induced by radiation therapy; 14）Any other clinically significant disease or condition (such as uncontrolled diabetes, active or uncontrolled infections, etc.) that the investigator believes could affect protocol adherence or affect the patient's ability to sign up for ICF; 15）Spinal cord metastases with potential risk or symptoms of spinal cord compression； 16）The second cohort received ROS1 inhibitors other than crizotinib； 17）The patient had uncontrollable amounts of pleural effusion, ascites, and pericardial effusion.

Where this trial is running

Bengbu, Anhui and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced CancerAdvanced Solid TumorLung Cancer, Nonsmall CellALK-rearrangedALK-positiveROS1-rearrangedROS1-positive
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.