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NCT Number: NCT06727812

Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors

This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.

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Key information

Conditions

Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage;
  • Age 18~75 years old;
  • At least one measurable lesion per RECIST v1.1 criteria;
  • ECOG PS score: 0-1.

Exclusion criteria

  • History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  • The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1;
  • He has severe cardiovascular and cerebrovascular diseases;
  • Severe infection within 4 weeks prior to the first dose.

Treatment and study plan

HRS-6208

Drug

HRS-6208.

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: From Day 1 to 30 days after the last dose.

  2. Maximum tolerated dose (MTD)

    Time frame: From Day 1 to 21 days after the first dose.

  3. Dose limiting toxicity (DLT)

    Time frame: From Day 1 to 21 days after the first dose.

  4. Recommended phase 2 dose (RP2D)

    Time frame: From Day 1 to 30 days after the last dose.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).

  2. Duration of Response (DoR)

    Time frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).

  3. Disease Control Rate (DCR)

    Time frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).

  4. Progression free Survival (PFS)

    Time frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).

  5. Overall Survival (OS)

    Time frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).

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Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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