Recruiting
Phase 1

SYS6043

Sponsor:

Conjupro Biotherapeutics, Inc.

Code:

NCT07424547

Conditions

Cancer

Solid Tumor Cancer

Advanced Metastatic Cancer

Prostate

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SYS6043

Study Details

Brief summary:

The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works.

Participants will:

  • Provide written informed consent
  • Undergo screening tests to ensure they are eligible for study treatment
  • Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment.
  • Have safety follow-up (SFU), and long-term follow-up.
  • Be followed until progression.

Conditions

Cancer

Solid Tumor Cancer

Advanced Metastatic Cancer

Prostate

Small Cell Lung Cancer

Study ID

NCT07424547

Start date

Mar 3, 2026

Status verified date

Mar, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Major:

  • Aged ≥18 years old (on the date of signing the ICF).
  • Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy.
  • Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled.
  • Expected life expectancy of ≥ 3 months.
  • ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment.
  • LVEF ≥ 50% as shown by ECHO or MUGA within 28 days prior to enrollment.

Exclusion Criteria:

Major:

  • Prior B7-H3 targeted therapy.
  • Previously received drug therapy with topoisomerase inhibitor antibody-drug conjugate (e.g., trastuzumab deruxtecan).
  • Symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class II-IV) or a history of severe arrhythmia requiring treatment.
  • History of myocardial infarction or unstable angina within 6 months prior to enrollment.
  • Based on the results of three 12-lead electrocardiogram (ECG) examinations, the mean QT interval (QTcF) corrected by the Fridericia formula for both males and females is prolonged to >470 ms.
  • Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.
  • History of interstitial lung disease (e.g., ILD/non-infectious pneumonia requiring glucocorticoid treatment in the past), or currently have interstitial lung disease, or are suspected to have such diseases through imaging examinations during screening.
  • History of underlying lung disorders, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive pulmonary disease, and other clinically significant lung injuries or requiring supplemental oxygen.
  • Any autoimmune diseases, connective tissue disorders, or inflammatory diseases involving the lungs recorded or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
  • Presence of uncontrolled infection requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs.
  • Active and clinically significant bacterial, fungal, viral infection, or Hepatitis C infection at screening (HCV antibodies test positive and HCV-RNA levels higher than the lower limit of quantification or 1000 copies/mL (whichever is lower); HIV antibody positive or syphilis antibody positive (with confirmation)..
  • HBsAg positive and HBV-DNA above the lower limit of quantification or 1,000 copies/mL (500 IU/mL) (whichever is lower). Liver tumor: For participants with liver metastases and HBV infection, HBV DNA must be <2000 IU/mL before the first dose. Participants who are HBsAg-positive and/or HBV DNA-positive should receive at least 2 weeks of anti-Hepatitis B virus treatment prior to the first dose and be willing to continue treatment during the study.
  • Lactating women (women who are willing to temporarily discontinue breastfeeding will also be excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.
  • Presence of spinal cord compression or clinically active brain metastasis, and/or meningeal metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants.

Study Design

Enrollment

386 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase Ia dose escalation is the first part (Part 1) of this study.

The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D (Recommended phase II dose).

experimental: Phase Ia PK expansion (Part 2).

Phase Ia PK expansion (Part 2) will be conducted at 2-3 dose levels deemed acceptable (≤MTD) in terms of safety/tolerability as assessed by the SMC, to further evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of SYS6043.

experimental: Phase Ib cohort expansion (Part 3).

Phase Ib cohort expansion (Part 3) will further evaluate the safety and efficacy of SYS6043 at the selected RP2D dose (1-2 dose levels).

Based on the obtained clinical study data and the participants' benefit/risk assessments, the SMC may consider initiating some or all of the following cohorts and may terminate enrollment for certain cohorts early based on clinical study data after initiation:

Cohort 1: Extensive-stage small cell lung cancer (ES-SCLC) after treatment failure of systemic standard of care; Cohort 2: Advanced/unresectable or metastatic HR+ HER2- breast carcinoma Cohort 3: Advanced/unresectable or metastatic castration-resistant prostate cancer (mCRPC) after treatment failure of systemic standard of care. Participants with prostate cancer whose disease is limited to metastases to bone will comprise no more than 20% of the enrolled population; Cohort 4: Advanced/unresectable or metastatic ovarian carcinoma

Interventions

SYS6043

Administered by intravenous injection

Primary outcome measure

  • Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a). [ Time Frame: An average of 1 year. ]
  • Incidence of Treatment-Emergent Adverse Events and dose-limiting toxicities (DLTs) [Safety and Tolerability] of SYS6043 during the study (Phase 1a) [ Time Frame: An average 1 year ]

Central Contacts and Locations

Central contacts

Director, Clinical Operations

609-356-0210clinicaltrials.gov@cspcus.com

Regulatory Operations Manager

609-356-0210clinicaltrials.gov@cspcus.com

Locations

BRCR Global

Recruiting

Plantation, Florida, United States, 33322

Contacts

Dr Sawhney, Principal Investigator

561-447-0614

Principal Investigator:

Dr Sawhney

Florida Clinical Trials Group

Recruiting

Plantation, Florida, United States, 33322

Contacts

Dr Amin, Principal Investigator

772-297-3057

Principal Investigator:

Dr Amin

NEXT Oncology Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Dr Sahota, Principal Investigator

210-580-9500

Principal Investigator:

Dr Sahota

NEXT Oncology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Dr Sommerhaulder, Principal Investigator

210-580-9500

Principal Investigator:

Dr Sommerhalder

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Dr Salkeni, Principal Investigator

210-580-9500

Principal Investigator:

Dr Salkeni

More Information

Sponsor

Conjupro Biotherapeutics, Inc.

Last update posted

Apr 7, 2026

Last verified

Mar, 2026

Keywords

  • ovarian cancer
  • breast cancer
  • small cell lung cancer
  • prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Conjupro Biotherapeutics, Inc. on 2026-04-07.