Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Plain English Summary

Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors is a Phase 1 clinical trial sponsored by Conjupro Biotherapeutics, Inc. studying Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer, Prostate, Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer. This study tests a new drug called SYS6043 for adults with advanced or metastatic solid tumors. It is for patients whose cancer has spread or cannot be treated with standard therapies. Participation involves receiving the drug by IV infusion every 3 weeks and attending regular study visits. Alternative treatments depend on the specific cancer type and previous treatments. The trial aims to enroll 386 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced or metastatic solid tumors that have not responded to or are not treatable with standard therapies. Patients must have at least one measurable tumor and a life expectancy of at least 3 months. Individuals with certain heart conditions, lung disorders, or active infections may not be eligible. Those who have previously received B7-H3 targeted therapy or specific antibody-drug conjugates are excluded. This trial is studying Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer, Prostate, Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will determine the highest safe dose of SYS6043 and identify any serious side effects, helping doctors understand how much of the drug can be given safely to patients. The specific primary outcome measures are: Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a). (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) (An average 1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it explores a new treatment option for patients with advanced solid tumors who have limited or no other treatment choices, aiming to fill a gap in care. This research targets Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer, Prostate, Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer, where improved treatment options are needed.

Investor Insight

This Phase 1 trial of SYS6043, targeting the B7-H3 protein, signals potential for a new therapy in a broad range of solid tumors, with early efficacy signals being closely watched by investors. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if SYS6043 is a suitable option for your specific cancer and if you meet all eligibility requirements. Be prepared for regular visits for drug infusions, blood tests, and scans to monitor your health and the cancer's response. Understand that this is an early-stage study, and the main focus is on safety and finding the right dose. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 386 participants

Interventions

• DRUG: SYS6043 — Administered by intravenous injection

Primary Outcomes

• Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a). (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) (An average 1 year)

Secondary Outcomes

• SYS6043 Pharmacokinetic (An average 1 year)
• SYS6043 Pharmacokinetic (An average 1 year)
• SYS6043 Pharmacokinetic (An average 1 year)
• SYS6043 Pharmacokinetic (An average 1 year)
• Objective response rate (ORR) (An average 1 year)

Full Eligibility Criteria

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.

Trial Locations

• BRCR Global, Plantation, Florida, United States
• Florida Clinical Trials Group, Plantation, Florida, United States
• NEXT Oncology Austin, Austin, Texas, United States
• NEXT Oncology San Antonio, San Antonio, Texas, United States
• NEXT Oncology Virginia, Fairfax, Virginia, United States

Frequently Asked Questions

Related Conditions

• Cancer
• Solid Tumor Cancer
• Metastatic Cancer
• Prostate Cancer
• Small Cell Lung Cancer
• Ovarian Cancer
• Breast Cancer
• Oncology
• Immunotherapy
• Targeted Therapy

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