A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies

NCT06224855 | Recruiting Phase 1

• 1 other identifier: DXC006-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.

Conditions

Advanced Solid Tumors; Hematological Malignancies

Outcome Measures

Primary Outcomes (2)

• Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.

  Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.

  28 days

• Number of participants with adverse events (AEs)

  The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.

  After first infusion of study drug, Through study completion an average of 1 year

Secondary Outcomes (13)

• Maximum observed serum or plasma concentration (Cmax)

  Through study completion an average of 1 year

• Maximum serum drug time（Tmax）

  Through study completion an average of 1 year

• Apparent volume of distribution(Vd)

  Through study completion an average of 1 year

• Volume of distribution at steady state (Vss)

  Through study completion an average of 1 year

• Terminal phase elimination half life (t½)

  Through study completion an average of 1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Dose Escalation DXC006, Cohort Expansion DXC006

Drug: DXC006

Interventions

DXC006 DRUG

Dose escalation period: DXC006 is administered intravenously every two weeks (Q2W) at the dose corresponding to the enrolled dose cohort. Dose expansion period: DXC006 is administered intravenously Q2W at the corresponding dose.

Also known as: Recombinant Humanized Antibody-drug conjugate

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient voluntarily signed the informed consent form and followed the protocol requirements.
• Gender is not limited.
• Age ≥ 18 years old.
• Expected survival time ≥ 3 months.
• The Eastern Cooperative Oncology Group (ECOG) score 0-2.
• Subjects may provide biopsy or archival tumor tissue samples for the central laboratory to confirm expression levels of Target protein.
• Patients with solid tumors or hematologic tumors who have failed standard therapy, including small cell lung cancer, multiple myeloma, neuroblastoma, etc..
• Patients who have received ASCT treatment must meet the following conditions:
• ASCT \> 100 days from start of study treatment.
• no active infection.
• Toxicity from prior antineoplastic therapy has recovered to Grade ≤ 1 (except alopecia) as defined by NCI-CTCAE v5.0, including peripheral neuropathy ≤ Grade 2.
• Organ function must meet the following requirements: blood routine:
• (1) Patients with multiple myeloma: absolute neutrophil count (ANC) ≥ 1.0×109/L (previous use of granulocyte colony-stimulating factor \[G-CSF\] is allowed, and G-CSF is not allowed within 7 days before laboratory examination during the screening period);Platelet count ≥ 50×109/L (platelet transfusion is not allowed within 7 days before laboratory tests during the screening period).
• Hemoglobin (HGB) ≥ 75 g/L (prior red blood cell \[RBC\] transfusions or recombinant human erythropoietin are allowed; Within 7 days before the laboratory examination during the screening period, red blood cell transfusion is not allowed).
• (2) Other patients: Absolute neutrophil count (ANC) ≥ 1.5×109/L, Platelet count ≥ 100×109/L, Hemoglobin (HGB) ≥ 90 g/L Liver: total bilirubin (TBIL) ≤ 1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert's syndrome (direct bilirubin ≤ 1.5×ULN); Glutamate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 3.0×ULN.

You may not qualify if:

• Within 14 days before the first dose: received plasmapheresis; Treatment with \> 10 mg of prednisone or equivalent doses of systemic corticosteroids per day for more than 3 consecutive days (short-term use for the prevention of contrast allergy can be enrolled).
• Patients have received systemic anti-myeloma therapy or investigational drug therapy within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; Radiotherapy within 14 days prior to the first dose.
• Patients have received monoclonal antibody therapy within 30 days before the first dose.
• Patients have received autologous hematopoietic stem cell transplantation within 100 days before the first dose.
• Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation.
• Patients have received the same targeted therapy in the past (limited to phase Ia clinical trials).
• Patient has symptomatic brain metastases or meningeal metastases.
• The patient had symptomatic amyloidosis, active plasma cell leukemia, and active POEMS syndrome at the time of screening.
• There is evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 ms (QT interval must be corrected by Fridericia formula \[QTcF\]). b. Evidence of currently clinically significant, untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as degree 2 (Mobitz type II) or degree 3 atrioventricular conduction (AV) block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty, or stenting or bypass grafting within 6 months prior to screening. d. Grade III or IV heart failure(New York Heart Association Functional Grading System). e. Uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• The patient has difficulty breathing or currently requires continuous oxygen therapy, or currently has active pneumonia or interstitial lung disease (except for mild cases as determined by the investigator).
• The patient has a history of other primary malignancies, except the following: cured malignancies with a very low risk of recurrence within 5 years, such as skin basal cell carcinoma and skin squamous cell carcinoma, carcinoma in situ of the cervix or breast.
• Patients have severe unhealed wound ulcers or fractures, or have undergone major surgery within 28 days prior to dosing or are expected to undergo surgery during the clinical study.
• Previous history of allergy to any component or excipient of DXC006.
• Active hepatitis B (HBV-DNA greater than the central upper limit of normal or HBV-DNA testing greater than 1000 copies /mL); Hepatitis C infection (positive for hepatitis C antigen or positive for hepatitis C RNA PCR).
• Seropositive for human immunodeficiency virus (HIV); Active syphilis (patients with positive syphilis antibodies can be included); Possible active tuberculosis (chest imaging within 3 months prior to first dosing indicating active tuberculosis infection).

Sponsors & Collaborators

• Hangzhou DAC Biotechnology Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510050, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Prof. Zhang Li

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Zhang Li

CONTACT

+86-020-87343565; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose 1:Drug(DXC006), Dose 2:Drug(DXC006), Dose 3:Drug(DXC006), Dose 4:Drug(DXC006), Dose 5:Drug(DXC006), Dose 6:Drug(DXC006).

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 25, 2024
• Study Start: January 24, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)