Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)

NCT ID: NCT04152499

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2026-07-16

Brief Summary

A Phase I-II, First-in-Human Study of SKB264 (Sac-TMT; MK-2870) in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types:

1. Triple negative breast cancer

2. Epithelial ovarian cancer

3. Non-small cell lung cancer

4. Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma

5. Small cell lung cancer

6. HR+/ HER2-breast cancer

7. Head and neck squamous cell carcinoma

8. Endometrial carcinoma

9. Urothelial carcinoma

10. Cervical cancer

Detailed Description

This is an open label, Phase I-II, first in human (FIH) study for SKB264 as monotherapy in patients who have locally advanced unresectable or metastatic solid tumor that is refractory to all standard therapies. TROP2 (trophoblast antigen 2) assessments will not be performed prior to enrollment but it will be assessed retrospectively. Confirmation of TROP2 (trophoblast antigen 2) expression by immunohistology or other means is not required, but the Sponsor will request fresh tumor biopsy or tissue specimens from archived materials for determination of TROP2 (trophoblast antigen 2) expression retrospectively. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy whose tumor is refractory to standard therapies. Patients will receive study drug as a single IV infusion at the prescribed dose level at each administration. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II).

Conditions

Epithelial Ovarian Cancer; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Urothelial Carcinoma; Non-Small Cell Lung Cancer; Small-Cell Lung Cancer; Endometrial Carcinoma; Head and Neck Squamous Cell Carcinoma; Breast Cancer; Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I: Dose Escalation

Five dose levels have been selected for evaluation in the Phase I part of the study: 2, 4, 6, 9, and 12 mg/kg of SKB264

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Triple Negative Breast Cancer

Histologically documented or cytologically , incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Epithelial Ovarian Cancer

Histologically documented or cytologically, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Non-Small Cell Lung Cancer

Histologically documented or cytologically, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Histologically or cytologically documented, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Extensive-stage Small Cell Lung Cancer

Histologically documented or cytologically, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: HR+/ HER2- Breast Cancer

Histologically documented or cytologically, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Head and Neck Squamous Cell Carcinoma

Histologically documented or cytologically, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Endometrial carcinoma

Histologically documented or cytologically, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Urothelial carcinoma

Histologically or cytologically documented, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Phase II: Cervical Cancer

Histologically or cytologically documented, incurable, locally advanced or metastatic cancer

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Interventions

SKB264

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Intervention Type: DRUG

Other Intervention Names

MK-2870; Sacituzumab Tirumotecan (Sac-TMT)

Eligibility Criteria

Inclusion Criteria

Patients must meet the following criteria for inclusion into the study:

Phase I:

1. Patients must be able to provide documented voluntary informed consent.

2. Male or female patient aged 18-75 years.

3. Histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include but not limited to the following tumor types:

Breast cancer Ovarian epithelial cancer Non-small cell lung cancer Gastric adenocarcinoma Small cell lung cancer Urothelial carcinoma Note: Confirmation of TROP2 expression by immunohistology or other means is not required, but the Sponsor will request tissue specimens from fresh or archived materials for determination of TROP2 expression.

4. Measurable disease by CT/MRI during dose escalation.

5. Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or standard treatment is not applicable at this stage.

6. Granulocyte count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.

7. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.

8. Serum bilirubin ≤ 1.5 mg/dL (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ×ULN may be enrolled)., aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN).

9. Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas. Note that 24 hour urine collection is not required but is allowed.

10. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment. Female and male patient treated with SKB264 should continue contraception use for 7 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.

• Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom.
• Women are excluded from birth control if they had had tubal ligation or a hysterectomy.

12. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo.

13. Expected survival ≥ 3 months.

Phase II:

1. Patients must be able to provide documented voluntary informed consent.

2. Male or female patient aged ≥ 18 years.

3. Histologically or cytologically documented, incurable, locally advanced, recurrent or metastatic cancer, including the following tumor types:

• Cohort 1: triple negative breast cancer (< 1% expression for estrogen receptor [ER] and progesterone receptor [PR] and HER2 negative)
• Cohort 2: ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
• Cohort 3: non-small cell lung cancer
• Cohort 4: gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (HER2 negative)
• Cohort 6: HR+/ HER2- breast cancer (≥1% expression for ER and/or PR and HER2 negative)
• Cohort 7: Head and neck squamous cell carcinoma (including primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Other primary tumor sites of HNSCC are not eligible)
• Cohort 8: Endometrial carcinoma (including carcinosarcoma, but excluding sarcoma and neuroendocrine endometrial carcinoma)
• Cohort 9: Urothelial carcinoma (including urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, patients with mixed histology are eligible provided urothelial component > 50% and plasmacytoid component<10%, patients whose tumors contain any neuroendocrine component are not eligible)
• Cohort 10: Cervical cancer (including squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix) Note: Evaluation of TROP-2 expression is required.

4. Measurable disease by CT/MRI.

5. Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies.

6. Neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.

7. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.

8. Serum bilirubin ≤ 1.5 ×ULN (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ×ULN may be enrolled), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN).

9. Creatinine clearance ≥ 30 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or Modification of Diet in Renal Disease (MDRD) formulas. Note that 24 hour urine collection is not required but is allowed.

10. ECOG Performance Status 0 or 1.

11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment. Female and male patient treated with SKB264 should continue contraception use for 6 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.

• Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom.
• Women are excluded from birth control if they had had tubal ligation or a hysterectomy.

12. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. Note: Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.

13. Expected survival ≥ 3 months.

Exclusion Criteria

Patients that meet the following criteria will be excluded from entry into the study:

Phase I:

1. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).

2. Symptomatic brain metastases or any radiation or surgery for brain metastases within 1 months of first infusion of study drug.

3. Subjects with second primary cancers (except for cured in situ non-melanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years).

4. Require supplemental oxygen for daily activities.

5. Documented Grade ≥ 2 peripheral neuropathy.

6. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.

7. Subjects previously treated with TROP 2 targeted therapies.

8. Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment, or therapy with traditional Chinese medicines approved for anti-tumor treatment, etc.) within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug.

9. Any experimental therapy within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug.

10. Any major surgical procedure within 4 weeks of first infusion of study drug.

11. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis.

12. Have known prior positive test results or medical history for human immunodeficiency virus.

13. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%).

14. Subjects who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout Study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this study. List of representative examples of strong inhibitors or inducers of CYP3A4 is provided in Appendix III.

15. Pregnancy or lactation.

16. Left ventricular ejection fraction < 45% determined by echocardiogram or multiple gated acquisition scan.

17. Resting QTc > 480 msec at baseline.

18. Ascites requiring paracentesis ≥1 per week.

19. Symptomatic pleural effusion (< 90% oxygen saturation).

20. Subjects with non-infectious interstitial lung diseases (ILD) or medical history of pneumonia requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases.

21. New diagnosed thromboembolic events that requires therapeutic intervention over the last 6 months (patients with stable control of lower limb deep venous thrombosis are allowed).

22. The investigator considers other situations that patients are not appropriate to participate in this trial.

Phase II:

1. Any patient who was treated in the Phase I part of this study.

2. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).

3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or other active CNS metastases.

4. Patients with active second primary cancers (except for cured in situ non-melanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years, or other malignant cancers that have been cured and no evidence of recurrence).

5. Require supplemental oxygen for daily activities.

6. Documented Grade ≥ 2 peripheral neuropathy.

7. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.

8. Patients previously treated with TROP 2 targeted therapies at any time for early stage or metastatic disease.

9. Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment, or therapy with traditional Chinese medicines approved for anti-tumor treatment, etc.) within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug.

10. Any experimental therapy within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug.

11. Any major surgical procedure within 4 weeks of first infusion of study drug.

12. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis.

13. Have known prior positive test results or medical history for human immunodeficiency virus.

14. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%).

15. Subjects who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout Study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this Study. List of representative examples of strong inhibitors or inducers of CYP3A4 is provided in Appendix III.

16. Pregnancy or lactation.

17. Left ventricular ejection fraction < 45% determined by echocardiogram or multiple gated acquisition scan.

18. Resting QTcF > 480 msec at baseline.

19. Ascites requiring paracentesis >1 per week.

20. Symptomatic pleural effusion (< 90% oxygen saturation).

21. History of interstitial lung diseases (ILD) or non-infectious pneumonitis requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases.

22. New diagnosed thromboembolic events that requires therapeutic intervention over the last 6 months (patients with stable control of lower limb deep venous thrombosis are allowed).

23. Known allergic to any components of SKB264, including excipients (including polysorbate-20); or history of severe hypersensitivity to another biologic therapy.

24. The investigator considers other situations that patients are not appropriate to participate in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klus Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordi Rodon Ahnert, MD, PhD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

Los Angeles Hematology Oncology Medical Group

Glendale, California, United States

University of California Los Angeles

Los Angeles, California, United States

Florida Cancer Specialists and Research Institute

Sarasota, Florida, United States

START MidWest

Grand Rapids, Michigan, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, United States

Providence Cancer Institute, Franz Clinic

Portland, Oregon, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

MUHC,Glen - Women's Health Research Unit

Montreal, Quebec, Canada

Centro de Estudios Clínicos SAGA

Providencia, , Chile

Centro de Investigacion Clinica Bradford Hill

Santiago, , Chile

Pontificia Universidad Catolica de Chile - CICUC

Santiago, , Chile

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Cancer Hospital

Hefei, Anhui, China

AnHui Provincial Cancer Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Chinese PLA General Hospital (301 Hospital)

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Chongqing University Cancer Hosptital

Chongqing, Chongqing Municipality, China

900TH Hospital of Joint Logistics Support Force

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fujian Medical University Uion Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital Of Xiamen University

Xiamen, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital , Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer prevention Center

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Guangxi Medical University Cancer Center

Nanning, Guangxi, China

Hainan General Hospital

Haikou, Hainan, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang City Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Nanyang Center Hospital

Nanyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Tongji Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, Hubei, China

Union Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, Hubei, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The first people's hospital of Lianyungang

Lianyungang, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

First Hospital of Jilin University

Changchun, Jilin, China

Jilin Cancer Hospital

Changchun, Jilin, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Affiliated Hospital of Binzhou Medical College

Binzhou, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

Affiliated Hospital of Jining Medical College

Jining, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Obstetrics&Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Neijiang Second People's Hospital

Neijiang, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Zhejiang University School of Medical Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

National Cancer Center

Goyang-si, , South Korea

CHA Bundang Medical Center, CHA University

Gyeonggi-do, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Asan Medical Center

Seoul, , South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Gazi University Medical Faculty

Yenimahalle, Ankara, Turkey (Türkiye)

Countries

United States; Canada; Chile; China; South Korea; Turkey (Türkiye)

References

Ouyang Q, Rodon J, Liang Y, Wu X, Li Q, Song L, Yan M, Tong Z, Liu Y, Wainberg ZA, Wang Y, Geng C, Ulahannan SV, Yu G, Sharma MR, Wang X, Wang JS, Spira A, Zhao W, Sanborn RE, Cheng Y, Wang X, Liu G, Li Y, Ge J, Chartash E, Akala OO, Yin Y. Results of a phase 1/2 study of sacituzumab tirumotecan in patients with unresectable locally advanced or metastatic solid tumors refractory to standard therapies. J Hematol Oncol. 2025 Jun 6;18(1):61. doi: 10.1186/s13045-025-01705-2.

Reference Type: DERIVED

PMID: 40481574 (View on PubMed)

Zhao S, Cheng Y, Wang Q, Li X, Liao J, Rodon J, Meng X, Luo Y, Chen Z, Wang W, Yi T, Li Y, Yin Y, Xu H, Yu G, Mi Y, Fan Y, Wainberg ZA, Wang X, Su C, Yu Q, Lai S, Sun L, Zhuang W, Wang X, Yang J, Li Y, Ge J, Li J, Zhang L, Fang W. Sacituzumab tirumotecan in advanced non-small-cell lung cancer with or without EGFR mutations: phase 1/2 and phase 2 trials. Nat Med. 2025 Jun;31(6):1976-1986. doi: 10.1038/s41591-025-03638-2. Epub 2025 Apr 10.

Reference Type: DERIVED

PMID: 40210967 (View on PubMed)

Other Identifiers

KL264-01

Identifier Type: -

Identifier Source: org_study_id