Epithelial Ovarian CancerPhase 1/2MK-2870-001NCT04152499
Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
A Phase 1/2 study testing SKB264 in people with Epithelial Ovarian Cancer and Gastric Adenocarcinoma, run by Klus Pharma Inc. at 109 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Ovarian Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- SKB264
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,410 participants
- Where
- 109 sitesin 6 countries
- Study dates
- 28 Feb 2020to 30 Nov 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following criteria for inclusion into the study:
- Phase I:
- Patients must be able to provide documented voluntary informed consent.
- Male or female patient aged 18-75 years.
- 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.
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- Measurable disease by CT/MRI during dose escalation.
- 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.
- Granulocyte count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.
- 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).
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- 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.
- Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo.
- Expected survival ≥ 3 months.
- Phase II:
- Patients must be able to provide documented voluntary informed consent.
- Male or female patient aged ≥ 18 years.
- 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.
- Measurable disease by CT/MRI.
- Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies.
- Neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.
- 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).
- 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.
- ECOG Performance Status 0 or 1.
- 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.
- 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.
- Expected survival ≥ 3 months.
Who cannot join
- Patients that meet the following criteria will be excluded from entry into the study:
- Phase I:
- 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).
- Symptomatic brain metastases or any radiation or surgery for brain metastases within 1 months of first infusion of study drug.
- 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).
- Require supplemental oxygen for daily activities.
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- Documented Grade ≥ 2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.
- Subjects previously treated with TROP 2 targeted therapies.
- 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.
- Any experimental therapy within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug.
- Any major surgical procedure within 4 weeks of first infusion of study drug.
- Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis.
- Have known prior positive test results or medical history for human immunodeficiency virus.
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%).
- 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.
- Pregnancy or lactation.
- Left ventricular ejection fraction < 45% determined by echocardiogram or multiple gated acquisition scan.
- Resting QTc > 480 msec at baseline.
- Ascites requiring paracentesis ≥1 per week.
- Symptomatic pleural effusion (< 90% oxygen saturation).
- Subjects with non-infectious interstitial lung diseases (ILD) or medical history of pneumonia requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases.
- 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).
- The investigator considers other situations that patients are not appropriate to participate in this trial.
- Phase II:
- Any patient who was treated in the Phase I part of this study.
- 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).
- Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or other active CNS metastases.
- 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).
- Require supplemental oxygen for daily activities.
- Documented Grade ≥ 2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.
- Patients previously treated with TROP 2 targeted therapies at any time for early stage or metastatic disease.
- 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.
- Any experimental therapy within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug.
- Any major surgical procedure within 4 weeks of first infusion of study drug.
- Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis.
- Have known prior positive test results or medical history for human immunodeficiency virus.
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%).
- 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.
- Pregnancy or lactation.
- Left ventricular ejection fraction < 45% determined by echocardiogram or multiple gated acquisition scan.
- Resting QTcF > 480 msec at baseline.
- Ascites requiring paracentesis >1 per week.
- Symptomatic pleural effusion (< 90% oxygen saturation).
- History of interstitial lung diseases (ILD) or non-infectious pneumonitis requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases.
- 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).
- Known allergic to any components of SKB264, including excipients (including polysorbate-20); or history of severe hypersensitivity to another biologic therapy.
- The investigator considers other situations that patients are not appropriate to participate in this trial.
Trial locations and contacts
109 sites in 6 countries.
109 sites in 6 countries
China82 sites
Anyang City Cancer Hospital
Anyang, Henan
Beijing Cancer Hospital
Beijing, Beijing Municipality
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Chinese PLA General Hospital (301 Hospital)
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong
First Hospital of Jilin University
Changchun, Jilin
Jilin Cancer Hospital
Changchun, Jilin
Hunan Cancer Hospital
Changsha, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Cancer Hospital
Chengdu, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Chongqing University Cancer Hosptital
Chongqing, Chongqing Municipality
The Second Hospital of Dalian Medical University
Dalian, Liaoning
900TH Hospital of Joint Logistics Support Force
Fuzhou, Fujian
Fujian Cancer Hospital
Fuzhou, Fujian
Fujian Medical University Uion Hospital
Fuzhou, Fujian
Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Sun Yat-Sen Memorial Hospital , Sun Yat-sen University
Guangzhou, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Sun Yat-sen University Cancer prevention Center
Guangzhou, Guangdong
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Hainan General Hospital
Haikou, Hainan
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Zhejiang University School of Medical Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Anhui Cancer Hospital
Hefei, Anhui
AnHui Provincial Cancer Hospital
Hefei, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui
The Second Hospital of Anhui Medical University
Hefei, Anhui
Jinan Central Hospital
Jinan, Shandong
Shandong Cancer Hospital
Jinan, Shandong
Affiliated Hospital of Jining Medical College
Jining, Shandong
The First Hospital of Lanzhou University
Lanzhou, Gansu
The first people's hospital of Lianyungang
Lianyungang, Jiangsu
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Jiangxi Cancer Hospital
Nanchang, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jiangsu Province Hospital
Nanjing, Jiangsu
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Guangxi Medical University Cancer Center
Nanning, Guangxi
Nanyang Center Hospital
Nanyang, Henan
Neijiang Second People's Hospital
Neijiang, Sichuan
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Obstetrics&Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality
Shanghai East Hospital
Shanghai, Shanghai Municipality
Shanghai General Hospital
Shanghai, Shanghai Municipality
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Liaoning Cancer Hospital
Shenyang, Liaoning
Shengjing Hospital of China Medical University
Shenyang, Liaoning
The First Hospital of China Medical University
Shenyang, Liaoning
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Shanxi Cancer Hospital
Taiyuan, Shanxi
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Weifang People's Hospital
Weifang, Shandong
Hubei Cancer Hospital
Wuhan, Hubei
Tongji Hospital Tongji Medical College Huazhong University Of Science And Technology
Wuhan, Hubei
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
Wuhan, Hubei
Wuhan Union Hospital of China
Wuhan, Hubei
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian
Xiangyang Central Hospital
Xiangyang, Hubei
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan
Xuzhou Central Hospital
Xuzhou, Jiangsu
Yibin Second People's Hospital
Yibin, Sichuan
Henan Cancer Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhengzhou Central Hospital
Zhengzhou, Henan
United States10 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Los Angeles Hematology Oncology Medical Group
Glendale, California, 91204
START MidWest
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90404
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Providence Cancer Institute, Franz Clinic
Portland, Oregon, 97213
Florida Cancer Specialists and Research Institute
Sarasota, Florida, 34232
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
South Korea10 sites
Inje University Haeundae Paik Hospital
Busan
Kyungpook National University Chilgok Hospital
Daegu
National Cancer Center
Goyang-si
CHA Bundang Medical Center, CHA University
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Asan Medical Center
Seoul
Gangnam Severance Hospital, Yonsei University Health System
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Canada3 sites
MUHC,Glen - Women's Health Research Unit
Montreal, Quebec
Princess Margaret Cancer Centre
Toronto, Ontario
Sunnybrook Research Institute
Toronto, Ontario
Chile3 sites
Centro de Estudios Clínicos SAGA
Providencia
Centro de Investigacion Clinica Bradford Hill
Santiago
Pontificia Universidad Catolica de Chile - CICUC
Santiago
Turkey (Türkiye)1 site
Gazi University Medical Faculty
Yenimahalle, Ankara
About this study
Official title: A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies
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:
- Triple negative breast cancer
- Epithelial ovarian cancer
- Non-small cell lung cancer
- Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma
- Small cell lung cancer
- HR+/ HER2-breast cancer
- Head and neck squamous cell carcinoma
- Endometrial carcinoma
- Urothelial carcinoma
- Cervical cancer
Read the 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
- Being tested
- SKB264
- Keywords
- TROP2, ADC
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264Drug
Also called MK-2870, Sacituzumab Tirumotecan (Sac-TMT)
SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation | Experimental | 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 Receives: Drug: SKB264 |
| Phase II: Triple Negative Breast Cancer | Experimental | Histologically documented or cytologically , incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Epithelial Ovarian Cancer | Experimental | Histologically documented or cytologically, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Non-Small Cell Lung Cancer | Experimental | Histologically documented or cytologically, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma | Experimental | Histologically or cytologically documented, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Extensive-stage Small Cell Lung Cancer | Experimental | Histologically documented or cytologically, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: HR+/ HER2- Breast Cancer | Experimental | Histologically documented or cytologically, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Head and Neck Squamous Cell Carcinoma | Experimental | Histologically documented or cytologically, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Endometrial carcinoma | Experimental | Histologically documented or cytologically, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Urothelial carcinoma | Experimental | Histologically or cytologically documented, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
| Phase II: Cervical Cancer | Experimental | Histologically or cytologically documented, incurable, locally advanced or metastatic cancer Receives: Drug: SKB264 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Measured: Assess up to 12 months
Phase II: Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) [Complete Response (CR) + Partial Response (PR)] of SKB264 when administered intravenously (IV) as monotherapy at the RDEs to patients with metastatic or locally advanced unresectable tumors.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (15)
Phase I: Dose Limiting Toxicities (DLTs)
To determine the dose limiting toxicities (DLTs) of SKB264 when administered IV twice (on Days 1 and 15) every 2 weeks in 4 weeks (28 days) cycles as monotherapy to patients with metastatic or locally advanced unresectable tumors.
Measured: Day 28 days after first infusion of study drug
Phase I: Overall safety and tolerability profile
Percentage of patients with adverse events (AEs), serious adverse events (SAEs), AEs with Grade ≥ 3 per NCI CTCAE v5.0, adverse events of Special Interest (AESI) and AEs related to study drug.
Measured: from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first
Phase I: Preliminary efficacy based on ORR (Objective Response Rate)
ORR (Objective Response Rate) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + partial response (PR)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
Phase I: Preliminary efficacy based on DOR(Duration of Response)
To evaluate preliminary efficacy in patients treated with SKB264 as monotherapy based on DOR(Duration of Response).
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
Phase I: Preliminary efficacy based on PFS(Progression-Free Survival)
To evaluate preliminary efficacy in patients treated with SKB264 as monotherapy based on PFS(Progression-Free Survival).
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
Phase I: Preliminary efficacy based on OS(Overall Survival)
To evaluate preliminary efficacy in patients treated with SKB264 as monotherapy based on OS(Overall Survival)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
Phase I: Percentage of patients with ADA formation to SKB264.
To assess the incidence of anti-drug antibody (ADA) formation to SKB264.
Measured: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
Phase I: PK parameters for SKB264-ADC, SKB264 TAB, and free KL610023 payload.
To characterize the PK of SKB264-ADC, SKB264 TAB, and free KL610023 payload, such as Cmax
Measured: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
Phase II: Overall safety and tolerability profile
Percentage of patients with adverse events (AEs), serious adverse events (SAEs), AEs with Grade ≥ 3 per NCI CTCAE v5.0, adverse events of Special Interest (AESI) and AEs related to study drug.
Measured: from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first
Phase II: Efficacy based on DOR (Duration of Response)
To evaluate efficacy in patients treated with SKB264 as monotherapy based on DOR(Duration of Response)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months.
Phase II: Efficacy based on PFS (Progression-Free Survival)
To evaluate efficacy in patients treated with SKB264 as monotherapy based on PFS (Progression-Free Survival)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months.
Phase II: Efficacy based on OS (Overall Survival)
To evaluate efficacy in patients treated with SKB264 as monotherapy based on OS (Overall Survival)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months.
Phase II: Percentage of patients with ADA formation to SKB264.
To obtain Percentage of patients with ADA formation to SKB264.
Measured: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
Phase II: PK parameters for SKB264-ADC, SKB264 TAB, and free KL610023 payload
To characterize the PK of SKB264-ADC, SKB264 TAB, and free KL610023 payload, such as half life
Measured: From Cycle 1 to Cycle 6 and End of Treatment(EOT), approximately 12 months
Phase II: Levels of TROP2 expression in tumor tissue
To assess levels of TROP2 expression in tumor tissue and correlation of those levels with responses and toxicity.
Measured: Screening and End of Treatment(EOT), approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start28 Feb 2020
- Primary completion30 Nov 2025
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klus Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordi Rodon Ahnert, MD, PhD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152499
- Sponsor's protocol ID
- KL264-01
- Acronym
- MK-2870-001
- Status last verified
- May 2026
- First submitted
- 29 Oct 2019
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40481574Zhao 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.
PubMed 40210967